Patient Information Sheet and Informed Consent Form · 2020. 12. 15. · Patient Information Sheet and Informed Consent Form, Version 1.2 for United Kingdom dated 16Nov2020 adapted

Patient Information Sheet and Informed Consent Form, Version 1.2 for United Kingdom dated 16Nov2020 adapted on the basis of Master Study Information and Informed Consent Form, Version 2.0 12 November 2020 Protocol D8850C00002, AstraZeneca LP IRAS Number: 289956

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Patient Information Sheet and Informed

Consent Form There are [4] parts to this document:

Part I: the “Study Information” essential to your decision to take part in the clinical study,

Part II: the “Future Research Information” which explains the possibility to contribute to

future research, subject to an optional consent,

Part III: your “Consent Form” which summarise what you may agree to.

Part IV: supplementary information in the “Additional information for patients” Section,

including a glossary.

PART I: STUDY INFORMATION

Study title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in

Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two

Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19

Study protocol: D8850C00002

Study drug: AZD7442 or placebo, referred to throughout the document as the “study

medication

Sponsor of the study: AstraZeneca AB

Investigator: Dr Nicky Longley

Patient Name: ________________________

Patient Number:

Dear Madam/Sir,

You are invited to take part in this research study to test if AZD7442 is able to prevent

Coronavirus Disease 2019 (COVID-19). AZD7442 is a combination of two molecules AZD8895

and AZD1061. AZD8895 and AZD1061 are each a type of protein, called a monoclonal

antibody. Antibodies are protein molecules that your body produces to help fight infections.

Monoclonal antibodies are artificially produced, highly purified antibodies that can be


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manufactured to use as medical treatments. You are being asked to join this study because

you may be predisposed to have less protection from a COVID-19 vaccine than most adults,

or because you are at a higher risk of exposure to SARS-CoV-2 (the virus causing COVID-19).

Participation requires your written consent. Before you decide whether you want to participate

in this study, you will be given an explanation about what the study involves.

This study is being conducted by AstraZeneca AB, the study sponsor. Your study hospital/clinic

is being paid by AstraZeneca to do the research. AstraZeneca AB is responsible for your

personal information and any results from research described in this document is owned by

AstraZeneca AB.

The overall description of this study (including the collection, storage and use of your data and

biosamples collected from your blood, urine, , saliva or nose, as well as this document) has

been reviewed and has been given a favourable opinion in your country by London-Fulham

Research Ethics Committee to ensure that the rights, safety and well-being of study patients

are protected.

It has also been reviewed and approved by the UK regulatory body, the Medicines and

Healthcare products Regulatory Agency (MHRA).

You may or may not receive any protection from COVID-19 if you join the study. But the

information we get from this study might help to protect other people from COVID-19 in the

future.

If you registered to be part of a Covid-19 research study on the National Institute for Clinical

Research (NIHR) website, the study team will notify the NIHR of your participation in this study.


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1 What is this study about? We are doing this study to learn more about: AZD7442 and how effective it is in the prevention

of COVID-19 and also to better understand COVID-19 and associated health problems by

comparing to placebo (placebo is similar to AZD7442 but does not contain any active

medication. A placebo is used to check that any effects seen in people taking part in the study

are because of the study drug itself.). AZD7442 and placebo will be referred to together as the

“study medication”.

AZD7442 is considered experimental, which means it has not been fully tested, and is not

currently approved by any health authority, except for use in research studies like this.

About 5000 women and men, 18 years of age or older, will take part in this study. There will

be 2 groups in the study. Group 1 will be adults 60 years of age or older of whom about half

will be living in long-term care facilities, including skilled nursing facilities, assisted living

facilities, and independent living facilities for senior adults and Group 2 will be adults less than

60 years of age. The study will take place at approximately 100 sites in about 5 countries.

An independent committee will review safety data from the first 300 participants, which may

include you, and determine whether it is appropriate for the study to proceed. Therefore, there

will be a 7 day break period where the safety and data will be reviewed before more participants

are given the treatment.

2 Do I have to take part? You have a choice whether or not you would like to participate.

Please take as much time as you need to make a decision about whether or not you would like

to participate in this study. It may be helpful to talk with your friends and family as you make

this decision. If you agree to participate in this research study, you will be required to sign this

Informed Consent form. A copy of the signed Informed Consent form will be provided to you.

If you join the study, you can leave at any time (see “section 14” for more details). Leaving will

not affect your care. If you choose to leave the study, please let your study doctor know as

soon as possible.

Please consider the study time commitments and responsibilities as a research patient when

you are deciding to take part.

3 What will happen if I join the study? You will be in the study for about 1 year in total.

Before you can start the study medication you will undergo a series of tests. This is called

screening. If you meet the screening criteria you will be randomly assigned a study treatment.

“Randomly assigned” means that whatever treatment you get will be by chance, like flipping a

coin or drawing names out of a hat. You have a 2 in 3 chance of being given AZD7442. This


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study will be double-blinded meaning neither you or the study doctor will know which treatment

you receive. If you don’t meet the screening criteria, the reasons will be explained. Your study

doctor will talk to you about other possible treatments.

For the main study, there will be a total of 7 or 8 visits, including screening, over 1 year. You

will also receive a phone call, email, or text message every week to check if you have developed

any COVID-19 symptoms. Each visit may be different in length, from a short visit of around one

hour to around 3 hours. The first 15 participants will need to be observed for safety for 4 hours

after receiving study medication and will be contacted by phone for the first 4 days afterwards.

The next 285 participants will be observed for safety for 2 hours after receiving study

medication. If you are within these groups, the Day 1 visit could last between 4 to 6 hours. If

any of the first 300 participants experience a serious allergic reaction, the remaining 4700

participants will be monitored for 2 hours after receiving study medication. Otherwise, this

monitoring period will be 1 hour after receiving study medication for the remaining 4700

participants.

If you develop COVID-19 after receiving study medication, there will be an additional 4 visits to

your clinic/doctor over 28 days. These will be referred to as Illness visits. If you are unable to

leave your residence, a team member from the study’s staff will visit you where you live. If a

home visit is necessary and if it is permitted by local regulations, you will be visited by a study

nurse at your residence. The study nurse may check your health status (including medical

history, physical examination and vital signs) and collect nasal and blood samples for tests). If

possible, the same procedures will be done during home visits as during site visits. You will

also be required to collect a saliva sample at home on 4 separate days.

All participants will be contacted by phone at home weekly throughout the study. This will be

to monitor your safety and determine if you have any health issues. If you develop COVID-19

during the study, you will also be contacted at home twice during the 28-day Illness Visit

period to check on your overall health.

Your study doctor will explain what you have to do at each visit and the tests that you will have

during the study. If you cannot come to a visit, you must tell your study doctor.

You will be given study medication at one visit, at the beginning of the study, but not after the

study has ended.

The study medication will be administered at one time via 2 separate injections into the muscle

of your buttocks. Each dose of AZD7442 is 150mg and the total dose will be 300mg. Each

injection of AZD7442 is 1.5 mL in volume, about 1/3 of a teaspoon, and the total injected volume

will be 3 mL, about 2/3 of a teaspoon. Placebo will be equivalent volume, but no active

medication.


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Please note that the study, and your participation in the study, may be stopped earlier than

expected, for example for scientific or safety reasons (see “section 9” for more details).

4 What are the required tests and procedures? To conduct the study, some tests and procedures will have to be performed on you.

The following tests and procedures will be included:

• Demography and medical history - At the screening visit, you will be asked about your

previous and current medical conditions

• Weight and height - Your weight and height will be taken only at screening

• Physical examination - Evaluation of your body and its functions will be done at all on-

site visits of the main study

• Vital signs - Measurement of your pulse, body temperature, blood pressure, breathing

rate and oxygen levels will be done at all visits of the main study

• Electrocardiography (ECG) – Measurement of the electrical signals in your heart will be

done by placing sticky pads on your chest and limbs and produces a tracing. This

measurement will be done at screening, and the last visit of the study (or if you choose

to withdraw early from the study). If you develop COVID-19, an ECG measurement will

also be done at the last Illness Visit.

• Adverse Events (AE) – You will be asked to describe any unusual symptoms or

discomforts that you may have experienced from the time of signature of informed

consent throughout the study

• Concomitant medication – You will be asked about the medications that you are currently

taking and if there were any changes since your last visit

• Injection site inspection – the site of study medication injection will be inspected

immediately after receiving study medication, 30 minutes after receiving study

medication, and just before leaving the clinic on the first visit.

• Nasopharyngeal swab – A swab will be placed inside the nose until it reaches the back

of the throat to collect nasal secretions. This will be done to test for SARS-CoV-2 virus at

screening and prior to receiving study medication in the main study, and if you develop

COVID-19. It will be performed at each of the Illness visits.

• Nasal fluid sampling - A strip will be placed inside your nose to collect fluid. This fluid will

be used to measure the amount of study medication or to determine if your body develops

antibodies due to the infection from the SARS-CoV2 virus. If you develop Covid-19, this

will be collected at all Illness visits except Day 21.


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• Saliva Sampling – If you develop COVID-19, a saliva sample will be collected at each on-

site COVID-19 visit. You will also be required to collect a saliva sample at home during

the other Illness visits if you are able to do so.

• Blood Sampling. You will be asked to provide blood samples for the following

assessments:

− Laboratory safety assessments for routine health checks at all on-site visits in the

main study

− Blood sample to measure coagulation (how quickly your blood is able to clot). This

will be collected at screening. If you develop COVID-19, it will be collected at every

Illness visit.

− Blood pregnancy test in women of childbearing potential at screening only to

confirm a positive urine pregnancy test result at screening

− Serum sample to test for Follicle Stimulating Hormone (FSH). FSH is a hormone

that is present at higher levels in women who are post-menopausal. This will be

collected at the screening visit for females less than 50 years old who are

suspected to be post-menopausal.

− Serum sample to test for HIV and Hepatitis B and Hepatitis C. As these are

notifiable diseases, if you test positive, your study doctor may need to report this

result to applicable health authorities as per local law. If diagnosed with HIV,

Hepatitis B or Hepatitis C you will be treated according to your hospital’s standard

of care and referred to a specialist if necessary.

− Serum to measure the amount of study medication in your blood, and whether the

amount measured is enough to neutralise (inactivate) the virus at every on-site

visit of the main study. If you develop COVID-19, this will also be collected at

every Illness on-site visit

− Serum for anti-drug antibodies (ADA) to determine if your body has developed

any antibodies to the study medication at every visit of the main study, except Day

8 and Day 92

− Serum for SARS-CoV-2 antibodies to determine if your body has developed

antibodies due to infection from the SARS-CoV-2 virus, at every visit of the main

study.

− Serum for analysis of proteins and inflammatory biomarkers at every visit of the

main study. If you develop COVID-19, this will also be collected at each of the

Illness visits

− Blood to test for levels of B-cells and T-cells (2 important cells of our immune

system). This will be collected at Day 1 of the main study. If you develop COVID-

19, this will also be collected at the first and second Illness visits. This will be


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collected from the first 1,000 participants in the study, in situations where it is

feasible to do so

• Urine sampling – You will be asked to provide urine samples for routine health checks at

every on-site visit. If you are female, urine pregnancy test will be performed (only women

of childbearing potential) at every on-site visit. If you test positive, a blood pregnancy test

will be performed for confirmation.

• Digital Health Device – If you develop COVID-19, you will be asked to wear a device

when you come to the study site for your first Illness visit. The device will be supplied by

a company cooperating with Sponsor, called Current Health. You will be trained by study

staff on the use of the device. It should be worn continuously each day until instructed by

study staff to stop. This device will keep track of your vital signs such as:

− how fast you are breathing

− how your heart is beating

− your temperature

− how much oxygen is in your blood

− how much you move.

This information will be wirelessly sent to your care team for them to review. The data

from the device will be monitored and you may be called by a nurse service if it looks like

the device is not sending out information properly or if there is concern that your vital

signs are too high or too low. If there are issues with the device, you will need to call the

study centre so that study staff can help to fix the problem.

• Electronic Diary – It is very important that we hear directly from you about your experience

with symptoms and health-related quality of life. If you develop COVID-19 you will be

asked to report information about your COVID-19 symptoms electronically using a

handheld device similar to a mobile phone if you are able to do so. The device will be

supplied by a company cooperating with Sponsor, called IQVIA eCOA. Study staff will

provide the device to you at your first Illness visit. Your doctor or the designated personnel

from the clinic will train you on how to use the device and will make sure that you are

comfortable using it before the device is handed over to you to take home.

• Optional Genetic analysis – a blood sample may be collected for genetic information

The total amount of blood that will be taken during the main study is about 335 mL or about

23.5 tablespoons. If you develop COVID-19, an additional 175 mL or about 12.5 tablespoons

will be collected during the Illness visits. Additional blood tests may be performed if your Study

Doctor requires them for accurate evaluation of your health status or managing adverse effects.


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The complete list of tests and procedures, including their detailed schedule is available in “part

4: Additional Information for Patients”. This section also provides more details on biosamples

handling, collection and storage locations.

5 What are the optional tests and procedures? Genetic testing is optional in this study. If you agree, you may provide your consent by ticking

the checkbox in the consent form. If you don’t consent to the optional procedures, you can still

participate in this study.

Genetic analyses

A single blood biosample will be used to analyse your genetic information. This sample will be

collected at Day 1 of the main study, before receiving study medication or placebo. If this

genetic sample is not collected at Day 1 of the main study, it may be collected at any visit

until the end of the study. The genetic sample will be stored with AstraZeneca AB for up to

15 years in a biobank in Sweden. Please note that the location of the biosamples may change

at the request of the sponsor. The genetic sample will not be able to identify you. A unique

code will be used and will not include any of your personal information. The results of the

genetic testing will not be shared with you.

You can think of genetic information as a large instruction book that your body reads to

understand how it should be built and function. All humans have the same instruction book in

their body, but some words or letters may be different from one person to the other. Some of

those differences have no effect on your health but others can influence the likelihood of

developing a disease or affect how medicine to treat a disease will work. If genetic analyses

are done, they may involve all or part of your genetic information.

6 What are the risks of joining the study? There is a risk that AZD7442 does not prevent COVID-19 and you may still develop COVID-19

during the study. There is a possibility of no benefit at all if you receive placebo.

It is possible that some patients could have side effects that we do not know about yet.

Allergic reactions

Similar to other monoclonal antibodies and to other medications, some people may have

allergic reactions. These reactions can sometimes happen hours or days after the injection.

Symptoms may include swelling of the lips, breathing problems, fainting, dizziness, hives (a

rash with small red raised itchy lumps) or rash. Allergic reactions can potentially be life

threatening.

Serious allergic reactions which may include anaphylaxis could occur in patients taking

AZD7442. Anaphylaxis is a life-threatening allergic reaction, which would be diagnosed by a


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physician. The initial symptoms include severe difficulty breathing, a drop in blood pressure

and a rash. Without immediate medical treatment this condition can be fatal.

If any serious allergic reaction occurs after receiving the first of the two injections, the second

injection will not be given to you and the study doctor will monitor you for safety.

Please inform your physician immediately if you think you may be having a reaction.

If the study doctor is different from your general practitioner (GP), he/she will notify your GP of

your participation in the study and share relevant medical information (such as any side effects

you may have) with him/ her if necessary for managing your health and safety throughout.

Other Side Effects

AZD7442 does not have any human target, but in addition to allergic reactions, other potential

side effects may include:

• Antibody dependent enhanced disease: Antibody dependent enhanced disease is

a potential risk of more severe infections, especially viral ones. AZD7442 was

modified to minimize this risk.

The potential impact of AZD7442 on vaccines (including any developed COVID-19 vaccine) is

not known. There is a possibility that receiving AZD7442 prior to vaccine may result in the

vaccine to be less effective up to 1 year or more, or more or may cause a vaccine to have

other currently unknown side effects.

The study medication is given as an injection into the muscle of your buttocks. Injection of the

study medication through the needle may cause redness, itching, tenderness, or a rash.

Obtaining blood may sometimes cause pain at the site where the blood is collected from,

bruising, occasional light-headedness, and fainting, which is relatively rare.

Collecting a nasal or nasopharyngeal swab may be quite uncomfortable and you may feel

irritation during the collection. This irritation or discomfort should resolve shortly after

completing this procedure.

There is always a risk involved in taking an experimental medication but every precaution will

be taken to ensure your safety. If you suffer any side effects or injuries, or your condition gets

worse, tell your study doctor immediately so you can receive appropriate care.

Previous Studies Testing AZD7442

10 subjects to date have received AZD7442 intramuscularly (IM). Data are available from a

Phase 1 clinical trial that included 12 subjects injected IM either with 300 mg AZD7442 (10

subjects) or with placebo (2 subjects) and 12 subjects who received either a 300 mg


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intravenous (IV) dose of AZD7442 (10 subjects) or placebo (2 subjects). Data was collected

over an 8 day period of time.

In these 24 subjects, the following was observed:

1. There were no injection site reactions observed.

2. There were no serious side-effects reported.

3. No severe allergic reactions (hypersensitivity reactions) were reported

4. No physical examination abnormalities were noted.

5. The following adverse events (AEs) were reported by 4 subjects:

a. Headache

b. Backpain

c. Paresthesia (abnormal sensation of the skin)

d. Slight tremor in fifth finger

e. Energy increased

f. Lymphadenitis (swelling of lymph nodes)

g. Abdominal distention

h. Diarrhoea

This study remains ongoing and any new safety data will be shared with you as soon as it

becomes available. There is a possibility that new safety information is discovered when the

AZD7442 is given to a larger group of people. Even with this information, there is a risk that

you may experience any or all of these reactions.

There are always risks with taking a research medication. Your study doctor will carefully

check your health for your safety. It is important that you tell your study doctor if you have any

symptoms.

To read more about the other risks, turn to the additional risk information provided in “Part 4.”

Additional information for patients”.

Complete List of Risks, Side Effects, and discomforts

• AZD7442 does not prevent COVID-19

• You may still develop COVID-19 during the study.

• There is a possibility of no benefit at all if you receive placebo.


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• There is a possibility that receiving AZD7442 prior to a vaccine (including any

developed Covid-19 vaccine) may result in the vaccine to be less effective up to 1

year or more or more or may cause a vaccine to have other currently unknown side

effects.

• Unknown side effects

• Severe side effects

• Possible allergic reactions

o Swelling of lips

o Breathing problems

o Fainting

o Dizziness

o Hives (a rash with small red raised itchy lumps)

o Rash

• Anaphylaxis – a life-threatening allergic reaction

o Severe difficulty breathing

o Drop in blood pressure

o Rash

• Antibody dependent enhanced disease

o potential risk of more severe infections, especially viral ones.

• Redness, itching, tenderness or a rash at the site of the study medication injection

• Pain or bruising at the site of the blood test; occasional light-headedness, and

fainting, which are relatively rare when having your blood collected.

• Discomfort or irritation as a result of the nasal or nasopharyngeal swab collection.

This irritation or discomfort should resolve shortly after completing this procedure.

7 Are there any other considerations or risks I need to know about?

Pregnancy, contraception, and breast-feeding

Because the effects of AZD7442 on an unborn child or infant are not known you must not get

pregnant or breastfeed a child during the study. Females must use effective birth control from


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Day 1 and agree to continue for 12 months after receiving study medication. The study doctor

can discuss acceptable birth control methods with you. Males must agree to use a condom

from Day 1 and agree to continue for 12 months after receiving study medication. This

precaution is intended to prevent transmission of semen. Additional birth control measures are

not required for the female partners of men participating in this study.

If you or your partner become(s) pregnant, you must tell the study doctor immediately. If you

are female and become pregnant during the study, you will need to provide information about

your pregnancy and your baby. For males, if your partner becomes pregnant during the study,

your partner will be asked under a separate consent to provide information about your partner

and your baby.

Blood Donation

You must not donate blood from the time you sign this Informed Consent up until 12 months

after receiving study medication.

Egg or Sperm Donation

You must not donate any eggs (if you are female), or sperm (if you are male) during the study

and up until 12 months after receiving study medication.

Vaccinations

Some vaccinations are not allowed from when you sign this document until at least 30 days

after receiving the study medication. Please talk to your study doctor before you have any

vaccinations.

Other Research Studies

You are not allowed to take part in any other research study that involves receiving an

experimental treatment from 90 days prior to receiving study medication until completion of the

study. The one exception to this requirement is that, if you develop COVID-19, you are

permitted to participate in a study testing experimental treatments for COVID-19. If you have

any health care contact such as with a doctor or a dentist, tell them that you are in this research

study.

Medication Restrictions

Any other experimental medications for the treatment or prevention of COVID-19 will not be

allowed, unless you develop COVID-19 and are hospitalised during the study. Some other

medications cannot be started after receiving study medication. Please talk to your study doctor

before taking any new medication.

Safety Provisions for Covid 19


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Each site will implement a plan to minimise/prevent transmission of COVID-19 from infected

individuals to others, following facility/institution guidelines, and local or other restrictions.

8 What are the possible benefits of taking part? There is no certainty that you will have any benefit from the study medication.

The information the study sponsor receives from this study may help to prevent individuals

from developing COVID-19.

It is not certain that you will directly benefit from the participation in the study. Your participation

may, however, help other patients in the future by improving the knowledge of diseases and

improving medical care.

9 What happens if something changes while I am in the study, e.g.,

if new information is found? Changes may happen in the study that could make you change your mind about continuing to

take part. If something changes, we will tell you as soon as possible and a new Informed

Consent may need to be signed.

You can choose to leave the study at any time. For more details see section 14 below.

The study doctor can also choose to take you out of the study if they believe that it is best for

you.

Your participation in the study also stops when the Sponsor; health authorities, the ethics or

regulatory agencies decide that the study must be stopped.

10 What happens if I am harmed or injured during the study? If there is an emergency, call your family doctor right away or go to the accident and emergency

department and contact your study doctor as soon as you can. All relevant contact details can

be found in part 4: “Additional information for patients”.

If you become ill or are injured while you are in this research study, you must tell your study

doctor straight away.

Injuries that have been caused by the study medication, tests or procedures are called

‘research injuries’. Injuries caused by your usual medical care or from development of COVID-

19, are not research injuries.

Any compensation payable for any injury caused to you by taking part in this study will be in

line with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). The

Sponsor will not compensate you where the injury has happened because a procedure has

been carried out that is not in line with the study protocol or where the study doctor has acted

negligently. If the injury has happened because a procedure has been carried out that is not


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in line with the study protocol or where the study doctor has acted negligently the doctor has

professional insurance to cover compensation if negligence is proven.

The Sponsor has taken out an insurance policy to cover compensation for any personal injury

resulting from your taking the study drug, provided such personal injury is not due to fault or

negligence of the study doctor or his/her team.

If you have private medical insurance, please check with your insurance company that taking

part in this research study will not affect your cover.

Sponsor may also compensate you in accordance with the law of the United Kingdom and by

signing this form you do not give up any legal right you may have.

11 What will happen to my data and biosamples gathered in the

study?

a. Which data and biosamples are collected?

In order to conduct the study, the Study site will have to collect and register information about

your identity (such as your name, address, telephone number, email address and health

insurance number) as well as data that is necessary to assess your health conditions such as

your medical condition and medical history (this may include information from your physicians/

available in your medical records), your life style, your demographics (full date of birth, age,

gender, ethnic and racial background), and your genetic information. Data collected via i.e.

smartphone or websites devices and apps will also be part of your coded data. Your answers to

questionnaires using the handheld device provided in specific for the study will also be collected.

Your age and race/ethnicity collected in this study will be helpful in finding out how different

people respond to potential new medications. For more details about which data that is collected

in the study, see further details at the end of this document in “part 4: Additional information for

patients”.

In addition, the study site will collect biosamples from you (such as blood, urine, saliva and

nasal swabs). These will be analysed and the data derived from the analysis will be part of your

coded data which will also include genetic data.

b. What are my data and biosamples needed for?

Your data and biosamples are needed for the Sponsor to develop the drug, get permission to

introduce and keep it on the market, monitor its safety and get it reimbursed by governments

i.e., throughout the drug development programme. Therefore, they will be used as planned in

this study as well as within related research activities necessary for this drug development

programme in order to:


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• understand how the AZD7442 and similar medications work in the body (i.e., evaluate

the AZD7442 mode of action, alone or in combination with other medications).

• better understand the studied disease and associated health problems,

• learn from past studies to plan new studies or improve scientific analysis methods,

• publish research results in scientific journals or use them for educational purposes,

The legal basis for the use of your data for the above purpose is based on Sponsor’s legal

requirements that cover the conduct of clinical studies and public interest. (Further details can

be found at the end of this document in part 4: “Additional information for patients”)

Your biosamples will not be used for commercial profit.

c. Who can access my data and biosamples?

Your name and contact details will only be accessible to the study doctor and the site study

team to conduct the study. Non-medical personnel acting on behalf of the sponsor and being

bound by a duty of confidentiality as well as Health authorities may also be given access to

this data only to verify that the study is carried out in compliance with legal and quality

requirements.

The study site will share your data and biosamples with the sponsor but only after they have

been coded (which means that your name, contact details or health insurance number, have

been replaced by a code. For more information about coding, see details at the end of this

document in part 4: “Additional information for patients”).

The sponsor may share your coded data and biosamples with its Research partners and

Service providers for the purposes of the drug development programme.

In order to ensure proper conduct and accurate results of the study and to get permission to

market the drug, the sponsor will share your coded data with authorities and possibly with Ethics

Committees. They may also be shared with scientific journals, so the study results can be

reviewed by independent scientists and to ensure the accuracy of results.

In none of these cases your identity will be revealed.

Some of the above-mentioned persons may be located outside your country. If this other

country does not have equivalent personal data protection standards than your country,

appropriate Safeguards (such as contracts and technical Security measures) will be adopted

to protect and maintain the confidentiality of your data and biosamples as further described at

the end of the document in part 4: “Additional information for patients”.

In case another organisation takes over development or commercialisation of the study

medication, your coded data or biosamples may be transmitted to them. They will then have to

protect your data and biosamples in the same way as described herein.


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d. Who else may have access to my contact information and why?

Your contact details (including phone number and email) may be shared with service

providers (such as IQVIA eCOA and Current Health companies supplying electronic devices

mentioned above in section 4: “What are the required tests and procedures?”), in order to:

• Allow call-centres to reach you for telephone interviews related to the study.

• Set up and oversee your accounts required for managing your access to any apps or

other devices that are used in the study.

These service providers must keep your contact details private and will NOT share any

information that can directly identify you with the sponsor.

e. How long will my coded data and biosamples be kept?

The study site and the sponsor are obliged to keep all study data for 25 years after the end of

the study, unless there is a legal requirement for keeping them longer. Your coded data will

then be deleted or anonymised, and your biosamples destroyed as soon as possible after the

tests listed in section 4 for the drug development program are completed unless you authorise

the sponsor to use them for future research (a tick-box available in part 3: “Consent Form” will

allow you to make this choice). For more details about anonymising, see part 1 section 11g:

“What does anonymised data mean?” or internal Document Retention policy you may go to

ww.astrazenecapersonaldataretention.com

f. What are my rights under data protection law?

You have the right to review which of your data are collected and being used; you can also ask

for a copy of this data, ask for restriction of use of this data, or ask to have incorrect data

rectified. You may also ask the study doctor to receive a copy of the data you have provided

for the future research in a standardised electric format or to have them transmitted to another

person of your choice.

To ensure the scientific integrity of the study, you will not be able to review some of the data or

receive a copy of it until the study ends, because in this study, neither you nor the study doctor

know if you are receiving the AZD7442 or the placebo.

To exercise these restricted rights, please contact preferably the study doctor. Contact details

of the Data Protection Officer (DPO) are provided in part 4: “Additional information for

patients”. If there are issues related to the use of your data, you have the right to file a complaint

with your local data protection authority or with the sponsor’s.


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g. What does anonymised data mean?

Health authorities as well as pharmaceutical companies believe that access to clinical studies

data advances clinical science and medical knowledge and is in the best interest of patients

and public health, provided that patient privacy is protected. Therefore, the sponsor may

generate and share internally or with other researchers an anonymised set of your data

collected in the study (e.g., on www.clinicalstudydatarequest.com). This means your coded

data will be stripped of your Patient code as well as of any other information that could

reasonably be used to identify you such as your date of birth.

h. Remote Source Data Verification

Your medical files may be reviewed at the hospital (or study doctor’s office) or remotely (outside

of the study centre) in order to check the information and verify the clinical study procedures,

without breaking your confidentiality. If your medical files are reviewed remotely, the records

will include your study subject number but will not include your name or other directly

identifiable information, <unless these records will be reviewed directly through the study

centre’s secure electronic medical records portal>.

Whether your medical files are reviewed at the study centre or remotely for the purposes of

the study, your records will be kept secure during this process.

12 Expenses

If applicable, you may be reimbursed for reasonable expenses incurred due to your

participation in the study (for example: parking).

13 How to find out more after the study? Trial Result Summaries are a short and easy to understand summary of the results of this

study. These will be added to www.trialsummaries.com within 1 year when the last participant

completes the last visit for the study. You can visit www.trialsummaries.com website anytime

to sign up to be notified via email when the trial results summary of your study is available. Or,

please let your study doctor know if you need a printed copy of the document.

Technical Information about this research study will be posted on public websites:

http://astrazenecaclinicaltrials.com and https://www.clinicaltrialsregister.eu/. These websites

do not contain any information about you.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required

by U.S. Law. This Web site will not include information that can identify you. At most, the Web

site will include a summary of the results. You can search this Web site at any time.

http://www.clinicalstudydatarequest.com/

http://www.trialsummaries.com/


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14 What will happen if I want to quit the study? Your participation in the study is voluntary which means you can stop your participation at any

time. If you want to stop taking the study medication, want to have a modified visit schedule or

if you want to stop your participation, you should tell the study doctor.

If you stop participating in the study the study doctor will stop the collection of your data but

your previously collected data and biosamples will be kept and used to guarantee the validity

of the study and comply with regulatory requirements, as allowed by law. The study doctor will

then invite you to have an end of study examination to check your wellbeing. If you don’t show

up at a planned visit, the study doctor will try to reach you. If the study doctor cannot reach you,

public sources will be consulted to verify your wellbeing. This is important for study results. It is

not mandatory but would be helpful for the study if you explain to your study doctor why you

wish to stop your participation, in particular if you have experienced discomforts.

If you would like your data or biosamples not to be used after you quit the study, you must

inform the study doctor. In such case, your remaining biosamples will be destroyed as soon as

possible, but your coded data previously collected will be kept as required by clinical

regulations.

15 Who can answer any questions I may have? Remember, there are no stupid questions! Feel free to ask at ANY TIME! It is your right to be

fully informed before deciding to take part in this study as well as in the future research

proposed in part 2. You can contact the study doctor at any time at the address indicated in

part 4: ”Additional information for patients”.


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PART 2: FUTURE RESEARCH INFORMATION

In addition to participating in the clinical study, we would like to know if you would be willing

that your coded data and leftover biosamples collected in part 1 are used in future research

projects with appropriate ethical approval.

You are free to consent to the use of your coded data and biosamples for future research. If

you decide not to do so, you may still take part in the clinical study.

1 What is future research? Future research is important to advance science and public health. At present, however, it is

not possible to foresee all details of future scientific research projects. These future scientific

research projects are beyond the scope of the clinical study and use of sample and data as

outlined in part 1 and may occur whilst the study is ongoing or after the study has finished.

Your coded data and biosamples may only be used for scientific health-related research to find

new ways to detect, treat, prevent or cure health problems.

They may also be used jointly with information from other sources outside typical clinical

research settings, e.g. from public research databases. However, they will not be combined

with other information in a way that could identify you. Your coded data and biosamples may

also be anonymised for some of the future scientific research.

Some research projects may require the analysis of your genetic information You can think of

genetic information as a large instruction book that your body reads to understand how it should

be built and function. All humans have the same instruction book in their body but some words

or letters may be different from one person to the other. Some of those differences have no

effect on your health but others can influence the likelihood of developing a disease or affect

how medicine to treat a disease will work. If genetic analyses are done, they may involve all or

part of your genetic information.

2 How will my coded data and biosamples for future research be

handled? All biosamples will be securely stored on behalf of the sponsor for up to 15 years in a biobank

in Sweden and will be destroyed thereafter. Please note that the location of the biosamples

may change at the request of the sponsor.

Any additional data generated from your biosamples will be stored as long as necessary for

scientific research objectives and allowed by law and will be destroyed or anonymised

thereafter. For more information on Sponsors internal Document Retention policy you may go

to www.astrazenecapersonaldataretention.com

http://www.astrazenecapersonaldataretention.com/


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3 May my coded data and biosamples be shared? The sponsor may share your coded data and biosamples with research partners or deposit

them in scientific databases as described at the end of the document in part 4: “Additional

information for patients”. This may include researchers from universities, research hospitals,

and companies.

Some of the above-mentioned recipients may be located outside your country. The data

protection laws which apply in those countries may not be as stringent as the laws in your

country. Nevertheless, appropriate safeguards and security measures will be taken in order to

protect and maintain the confidentiality of your biosamples and coded data as described at the

end of the document in part 4: “Additional information for patients”.

4 How will my privacy be protected? Your coded data and biosamples will be subject to appropriate safeguards, as specified in part

4: ”Additional information for patients”, and will only be used for the purpose of scientific health

related research. They will not be used to contact you or to affect your care or any other decision

affecting your life such as insurance rates or employment opportunities.

You have the same rights as the ones described in the section “What are my rights under data

protection law?”.

5 What if I want to withdraw from future research? Your participation in future research is voluntary. You are entitled to withdraw your consent for

future research at any time, without giving a reason and without a negative effect on your

standard of medical care. If you wish to withdraw, please inform your study doctor.

You may still continue to participate in the clinical study even if you choose to withdraw from

future research.

If you withdraw from future research, your coded data and biosamples will not be used for future

research and your samples will be destroyed as soon as possible. Your coded data (either

copied from the clinical study database or newly generated) will also be destroyed unless this

information is already included in analyses or used in scientific publications or if the coded data

been anonymised and therefore we can’t identify your data or biosamples.

6 Results from Future Research? We may have to study coded data and biosamples from many people over many years before

we can know if the results of future research are meaningful.

Therefore, you should not expect to receive individual results from future research projects. We

will not give any such data to your doctor and we will not put them in your medical record as

they are not individual valid results.


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You are free to consent to the use of your coded data and biosamples for FUTURE

RESEARCH. If you agree, you can indicate this in the CONSENT FORM.


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PART III: CONSENT FORM

Study title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in

Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two

Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19

Study protocol: D8850C00002

Study drug: AZD7442 or placebo, referred to throughout the document as the “study

medication”

Sponsor of the study: AstraZeneca AB

Investigator: Dr Nicky Longley

Patient Name: ________________________

Patient Number:

I confirm that:

• The study doctor or study personnel delegated by the study doctor has explained the study to me comprehensively.

Patient initials

• I have had the opportunity to discuss the study with the study doctor and all my questions were answered.

Patient initials

• I have had an adequate amount of time to consider the study. Patient initials

• I have read and understood all the above information related to the study. Patient initials

• I understand that I will receive a copy of this document once I have signed it. Patient initials

• I understand that my decision to take part in the study is entirely voluntary. If I decide not to participate in the study or to stop my participation during the study, this will not affect my standard medical care.

Patient initials

• I will truthfully answer all questions about my medical history and will follow all rules listed in the document.

Patient initials

I consent to take part in the clinical study and study procedures described herein. I understand that my participation also entails:

• My name and contact details being collected during the study as described to me, and accessed and reviewed by listed authorised people;

Patient initials

• My personal information, including full date of birth and race/ethnicity, to be collected and used as part of this clinical study.

Patient initials


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• My coded data being used by the sponsor or by people or companies acting on its behalf or working with the sponsor;

Patient initials

• My coded data being used by persons or organisations located in countries that do not have data protection rules equivalent to those of my country. I understand that the sponsor monitors these uses and takes all possible measures to protect my privacy;

Patient initials

• If the study doctor is different from your GP, he/she will notify your GP of your participation in the study and share relevant medical information (such as any side effects you may have) with him/ her if necessary for managing your health and safety throughout. Please indicate name and contact details of your GP here:

Patient initials

• My biosamples being collected and analysed as described herein. Patient initials

I further understand that I can make a choice about the topics listed below and that by

putting my initials in the box “Yes” I do give consent and that by putting my initials in

the box “No” I do not give consent. If I do not provide consent to optional

tests/procedures, I may still participate in the main study:

My participation to optional tests/ procedures including genetic testing

YES

Patient initials

NO

Patient initials

The use of my coded data and biosamples for future research, as described

in “Part 2: Future Research Information”, and where necessary for the

research, possible analyses of my genetic information

YES

Patient initials

NO

Patient initials


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STUDY PARTICIPANT

FULL NAME

(capital letters)

DATE

(dd-Mmm-Year)

SIGNATURE

Signature of person conducting the informed consent discussion

FULL NAME

(capital letters)

DATE

(dd-Mmm-Year)

SIGNATURE

Impartial witness

FULL NAME (capital

letters)

DATE

(dd-Mmm-Year)

SIGNATURE


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PART IV: ADDITIONAL INFORMATION FOR PATIENTS

1 Contact details

Study doctor: Dr Shama Hamal Study Coordinator: Sarah Whittley

Phone No: 020 3151 3117

(09:00 – 17:00 Monday – Friday)

Phone No: 020 3151 3117

(09:00 – 17:00 Monday – Friday)

Address: The 52 Club, 52 Gower Street,

Bloomsbury, London, WC1E 6EB

Address: The 52 Club, 52 Gower Street,

Bloomsbury, London, WC1E 6EB

[email protected] [email protected]

24-hours Emergency Contact Phone No: 020 3151 0776

[England Only] Patient Advise and Liaison

Service (PALS)/[non-England] Independent

Advisor

020 344 73042

[email protected]


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2 Detailed list of visits

and Test/Procedures

Main Study

Assessment Screening Day 1 Day 8 Day

29

Day

58

Day

92

Day

183

Day

366

Discontinuation

Visit

Consent X

Eligibility X X

Physical Exam

and assessments X X X X X X X X X

Adverse Events X X X X X X X X X

Vital Signs X X X X X X X X X

ECG X X X

Injection Site

Inspection a X

Blood Sample b X X X X X X X X X

Genetic Blood

Sample (optional)

c

X

Urinalysis X X X X X X X X X

Pregnancy Test d X X X X X X X X X

Nasopharyngeals

wab for SARS-

CoV-2

X X

Study medication

Dosing X

Telephone/Email/

Text Contact X X X X X X X

a Immediately after receiving study medication, 30 minutes after receiving study medication, and before leaving the clinic on Day 1

b Please see text for specific blood sample tests. c Optional sample, if not taken at screening the sample may be taken at any visit until the final study

visit d Women of child bearing potential only


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Illness Visits

Assessment Day 1 Day 3* Day 5* Day 8* Day 11* Day 14 Day 21 Day 28

Physical Exam and

assessments X X X X

Adverse Events X X X X X X X X

Vital Signs X X X X

ECG X

Blood Sample a X X X X

Electronic Diary and

Digital Health Device X X X X X X X X

Nasopharyngeal swab

for SARS-CoV-2 X X X X

Saliva Sample X X X X X X X X

Nasal Fluid Sample X X X

Telephone Contact X X

*Conducted at-home by patient a Please see text for specific blood sample tests.

3 Detailed Study Tests and Procedures Schedules

Main Study

Type of Sample Amount

Collected Screening

Day 1

Day 8

Day 29

Day 58

Day 92

Day 183

Day 366

Discontinuation Visit

Laboratory safety samples for routine

health checks

5 mL

(about 1.5 teaspoons)

X X X X X X X X X


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Collected Scree

ning

Day

1

Day

8

Day

29

Day

58

Day

92

Day

183

Day

366

Discontinuat

ion Visit

Blood to measure coagulation (how

quickly your blood clots)

2 mL (about ½ a teaspoon)

X

Serum for HIV, Hepatitis B and

Hepatitis C

5 mL

(about 1.5

teaspoons)

X

Blood or urine pregnancy test

Blood: 2.5 mL

(about ¾ of

a teaspoon)

X X a X a X a X a X a X a X a X a

Blood for FSH b 2.5 mL

(about ¾ of a teaspoon)

X

Serum sample to measure SARS-

COV-2 antibodies

3 mL (about 2/3

of a teaspoon)

X

Serum sample to measure:

• SARS-CoV-2 antibodies

• the amount of study medication in

blood

• ADA

• protein and inflammatory biomarkers

30 mL

(about 2 tablespoons)

X X X X X X X X

Blood to test for levels of B-cells and T-

cells

16 mL

(about 1

tablespoon)

X

Optional Genetic sample 6 mL

(about 1.75 teaspoons)

X

Urine sample for routine health check N/A X X X X X X X X X

a Blood pregnancy test done if urine pregnancy test is positive b To confirm post-menopausal status in women < 50 years old

Illness Visits


Collected Day 1 Day 14 Day 21 Day 28

Blood to measure

coagulation (how quickly

your blood clots)

2 mL

(about ½ a

teaspoons)

X X X X

Blood to test for levels of B-

cells and T-cells

16 mL

(about 1

tablespoon)

X X


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Collected Day 1 Day 14 Day 21 Day 28

Serum sample to measure:

• SARS-CoV-2 antibodies

• the amount of study

medication in blood

• protein and inflammatory

biomarkers

20 mL

(about 1.5

tablespoons)

X X X X

4 Complete List of Personal Data collected

• IP Address

• Device ID

• Electronic diary recordings

• Vital signs

• Overall health status

5 Glossary

Your biosamples

All your biological samples collected during this study and related

to you, such as blood, urine, biopsy, as appropriate and listed in

section 4: “What are the required tests and procedures?”. All your

biosamples are coded which means that your name will not be

associated with them.


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Your coded data

All your data collected at the study site with your name and

contact details have been replaced by a code. This is done by the

study doctor who keeps the link between your name/ contact

details and the code to ensure your safety and confidentiality.

Coded information cannot identify you unless your study doctor

provides your name or contact details, where allowed by

applicable law.

Coded data is just another term for “pseudonymised data”, which

is used in the General Data Protection Regulation (GDPR), which

was preferred to render the document more readable.

Sponsor details

Sponsor: AstraZeneca AB, 151, 85 Södertälje, SwedenFor this

study, your coded data will be managed by IQVIA, an

international company headquartered in USA.

The sponsor has the overall responsibility for a clinical study.

Study site details The place where the clinical study is taking place and where you

will have to go for the planned visits.

Health authorities

Authorities who supervise the study, who approve the

commercialisation of the drug or who receive the adverse events

reporting, whether in your country or in other countries.

Research partners

Any organisation which collaborates with the sponsor within the

drug development programme or for future research.

Service providers

Any organisation bound to the sponsor by a contract, which may

conduct activities on behalf of the sponsor under its strict

instructions. This may include other researchers including so-

called “contracted research organisations” (CROs) and IT

companies hosting clinical data or providing IT services.


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Safeguards

Appropriate safeguards will be implemented to protect coded data

during and after the study and may include that:

− Access to the coded data will be limited to specific

individuals subject to confidentiality obligations (including

the obligation to not attempt to re-identify

individuals/decode the clinical data).

− The coded data will be protected with security measures

to avoid data alteration, loss and unauthorised accesses

and further de-identification techniques may be applied.

− A data protection impact assessment (DPIA) will apply to

identify and mitigate privacy risks, if any, associated with

each scientific research.

− When required by applicable law, scientific research is

subject to the approval of Ethics Committees.

− The coded data will not be shared for direct marketing

purposes or other purposes that are not legal duties or

are not considered scientific research according to the

applicable data protection legislation. In particular, it will

not be used to make decisions about future services

available to you, such as insurance.


32 of 35

Security measures:

How is my data

protected in other

countries?

The processing of your data starts at the study site. Your data will

then be transferred to several data experts to be verified and for

results to be calculated. In addition to having your data and

biosamples coded, your data is also protected by high standard

technical security means such as strong access control and

encryption. They are also protected legally by the following

means:

• Within the European Economic Area (EEA), the data privacy

laws and regulations are the same as [adapt as needed, in

particular for non-EEA countries: in your country].

• Outside the EEA, those countries are recognised by the

European Commission as providing an equivalent level of

data protection: Andorra, Argentina, Canada, Faroe Islands,

Guernsey, Israel, Isle of Man, Japan, Jersey and New

Zealand, Switzerland, Uruguay, and the United States of

America

• Within the sponsor group, your coded data are protected by

Binding Corporate Rules (BCR). You can find more

information about the Sponsors BCRs here:

www.astrazenecabindingcorporaterules.com

• In all other cases, your coded data are protected by

contractual arrangements, Codes of Conduct or certifications

which set the rules for personal information protection to

those available in European countries (this could for instance

be the case if the sponsor stores all its data with a US hosting

company) or other alternatives set forth in the law.

You may obtain further information as well as a copy of these

measures by asking your study doctor.

Restricted rights

Please note that the rights provided by the GDPR to get data

discarded (i.e., the right to be forgotten) as well as to get data

transmitted in a standard electronic format (i.e., right of portability)

do not apply to such studies.


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DPO (Data Protection

Officer) details

Study site DPO:

Matthew Hall

[email protected]; [email protected]

02034 479114 / 07946 535709

The Sponsor is the data controller for this study. If you wish to

contact the DPO of the sponsor, please be aware that your

name is not known there. You would need to link your identity to

your study participant number which may compromise the coding

of your data.

Sponsor DPO: AstraZeneca has assigned a data protection officer

responsible for overseeing AstraZeneca’s compliance with EU

data protection law, which you may contact at

[email protected].

Scientific research

Scientific research includes technological development and

demonstration, fundamental research, applied research and

privately funded research as well as studies conducted in the

public interest in the area of public health. This means that we

may use the data to advance our understanding of how to make

new medicines, medical devices, diagnostic products, tools

and/or other therapies, to treat diseases. We may also use this

data to improve the design and execution of future clinical

studies, services and treatments, for outcome research activities

and to aid in pricing and reimbursement activities.

mailto:[email protected]

mailto:[email protected]


34 of 35

Deposit in scientific

databases

To do more powerful research, it is helpful for researchers to

share data by placing data into one or more scientific databases.

Researchers can then study the data combined from several

research projects and learn even more about health and disease.

If you agree to take part in future research, some of your coded

data including genetic data might be placed into one or more

scientific database.

Researchers with an approved scientific research project may be

able to see and use your coded data, along with that from many

other people.

Your name and other information that could directly identify you

(such as address or social security number) will never be placed

into such a scientific database. Researchers will always have a

duty to protect your privacy and to keep your information

confidential.

Binding Corporate

Rules

Internal rules of multinational groups which set the minimum rules

for data protection to those available in European countries. You

can find more information about AstraZeneca’s BCRs here

http://www.astrazenecabindingcorporaterules.com/

EEA (European

Economic Area)

All European Union Member States as well as Norway,

Liechtenstein and Iceland.

Trial Result Summaries Also referred to by the EU as Lay Language Summaries

http://www.astrazenecabindingcorporaterules.com/


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Legal basis

You will participate in the clinical study only if you consent to it. If

you do so, data related to your health and to the study medication

must be collected and processed to evaluate the efficacy and the

safety of the tested drug, in accordance with legal requirements

from:

• The clinical trials (i.e., the EU clinical trial regulation

536/2014 which requires the sponsor to collect and

analyse such data before they are submitted to health

authorities),

• The EU regulations on pharmacovigilance which requires

follow-up and reporting of adverse events to the health

authorities, and

• Any other applicable law.

The use of your coded data and biosamples for future research

will only be possible if you provide optional consent for it.

Documents

Patient Information Sheet and Informed Consent Form · 2020. 12. 15. · Patient Information Sheet and Informed Consent Form, Version 1.2 for United Kingdom dated 16Nov2020 adapted