-
Please see the Informed Consent Form for complete details.
TEST. JOIN. RISE ABOVE.
THE ACTIV-2 STU
DY:
REVIEW OF
THE INFORMED
CONSENT FORM
-
Please see the Informed Consent Form for complete details.
THE ACTIV-2 STU
DY:
REVIEW OF
THE INFORMED
CONSENT FORM
TEST. JOIN. RISE ABOVE.
-
The ACTIV-2 Study is testing different medicines for adults with
COVID-19.
Today we’ll review:• Why we are doing this study• What to expect
during the study• Some potential risks and benefits
Being in the study is your choice!
Ask questions!
WELCOME TO
THE ACTIV-2
STUDY!
1
• Welcome to the ACTIV-2 Study!
• You have been asked to take part in theACTIV-2 Study because
you have beendiagnosed with COVID-19.
• The ACTIV-2 Study is testing differentmedicines to see if they
are safe and can helpadults with COVID-19.
• We will go over some important parts fromthe informed consent
form. You will be givena few different consent forms, but for now
wewill discuss the main informed consent form.This paperwork
contains all of the informationabout the study, including the
purpose of thestudy, visits and tests, and possible benefitsand
risks.
• Today we’ll review:• Why we are doing this study• What to
expect during the study• Some potential risks and benefits
• Being in the study is your choice.
• If you decide to join, your personal informationwill be kept
private.
• Ask any questions you may have.
Before we go over what a clinical study is, do you have any
questions about what we’re going to talk about today?
DISCUSSION QUESTION
Welcome
1
-
The ACTIV-2 Study is testing different medicines for adults with
COVID-19.
Today we’ll review:• Why we are doing this study• What to expect
during the study• Some potential risks and benefits
Being in the study is your choice!
Ask questions!
WELCOME TO
THE ACTIV-2
STUDY!
1
-
• A clinical study, or research study, is done tolearn more
about what a new medicine doesinside the body.
• Every medicine that you have ever taken hasbeen tested in a
clinical study.
• Studies are important because they see whatkind of side
effects a medicine may have and ifit can help the people who need
it.
Before we talk about the ACTIV-2 Study, do you have any
questions about clinical studies in general?
DISCUSSION QUESTION
What is a clinical study?
A clinical study is a research study to learn more about what a
medicine does inside the body.
• Are there side effects?
• Can it help people?
WHAT IS A
CLINICAL
STUDY?
2
2
-
A clinical study is a research study to learn more about what a
medicine does inside the body.
• Are there side effects?
• Can it help people?
WHAT IS A
CLINICAL
STUDY?
2
-
Researchers want to see which medicines:
WHY IS THE
ACTIV-2 STUDY
BEING DONE?
Can prevent people from having to go
to the hospital
Can get rid of the virus
Can help people get
better faster
Can keep people from getting sicker
Are safe for those who need them
Can help keep oxygen
levels up
3
• Right now there is no medicine proven to treatCOVID-19 in
people who are not sick enoughto be hospitalized.
• Researchers will be testing different medicinesthat they
believe are most likely to help peoplewith COVID-19.
• They want to see if these medicines:• Are safe for those who
need them• Can help people get better faster• Can get rid of the
virus• Can help keep oxygen levels up• Can keep people from getting
sicker• Can prevent people from having to go to the
hospital
Do you have any questions about why this study is being
done?
DISCUSSION QUESTION
Why is the ACTIV-2 Study being done?
3
-
Researchers want to see which medicines:
WHY IS THE
ACTIV-2 STUDY
BEING DONE?
Can prevent people from having to go
to the hospital
Can get rid of the virus
Can help people get
better faster
Can keep people from getting sicker
Are safe for those who need them
Can help keep oxygen
levels up
3
-
WHAT
HAPPENS
DURING THE
STUDY? Have in-person visits with tests and health checks.
Have phone calls or video chats with the researcher.
Fill out your study diary.
The study lasts 6 months. During this time you will:
4
• The whole study lasts about 6 months (24 weeks).
• During the study you would have in-personvisits with tests to
check on your health. Mostof these visits happen during the first
month ofthe study.
• You would also have phone calls or videos chatswith the
researcher from your home.
• The study team will give you a diary to keeptrack of your
temperature each evening andany symptoms you have. You’ll be asked
to fillout this diary for the first 28 days.
Do you have any questions about what happens during the study in
general?
DISCUSSION QUESTION
What happens during the study?
4
-
WHAT
HAPPENS
DURING THE
STUDY? Have in-person visits with tests and health checks.
Have phone calls or video chats with the researcher.
Fill out your study diary.
The study lasts 6 months. During this time you will:
4
-
WHAT
HAPPENS
FIRST??
• Give your permission by signing the informed consent form.
• Screening: Answer questions to make sure the study is right
for you.
5
• Before you decide whether to take part, readthe main informed
consent form and ask anyquestions that you may have.
• If you agree to be in the study, you will giveyour permission
by signing the informedconsent form. Make sure you understand
andagree to the study before signing.
• For each medicine being tested, there may be2 parts to the
study, called Phase 2 and Phase3. If you agree to join the study,
you would betold which phase is open for you to join.
• During the screening process, the study teamwill ask you
questions in person, over thephone, or by video chat to make sure
the studyis right for you.• They will ask you questions about
your
current and past health, any medicines youtake or have taken in
the past, and yoursymptoms of COVID-19.
• If you meet with the researcher in person,you may also have a
checkup.
Do you have any questions about the informed consent form and
giving your consent?
Do you have any questions about the screening process?
DISCUSSION QUESTIONS
What happens first?
5
-
WHAT
HAPPENS
FIRST??
• Give your permission by signing the informed consent form.
• Screening: Answer questions to make sure the study is right
for you.
5
-
WHAT
TREATMENT
MIGHT
I GET?
Each study medicine will be compared to a placebo.
Different medicines may be tested during the study at the same
time.
6
• If the study is right for you, you will have your firstvisit,
or entry visit, to meet with a researcher fortests and to be placed
in a treatment group.
• Each study medicine will be compared to aplacebo. A placebo
looks like the real drug butdoesn’t have any actual medicine in it.
This givesresearchers something to compare the studymedicine to.•
You would not know if you are receiving the
study medicine or placebo until the end of thestudy.
• If a standard treatment for COVID-19 is foundduring the study,
that treatment will be usedinstead of placebo.
• Different medicines may be tested during thestudy at the same
time.• One type of medicine you might receive is
called a monoclonal antibody. Antibodies arenaturally made by
your body to help fightdisease. Monoclonal antibodies are made in
thelab and help your body attack invaders, such asviruses, to keep
them from entering your cells.
• Once you are placed in a treatment group, you willreceive more
information on that medicine beingtested, including any possible
side effects.
Do you have any questions in general about the treatment
groups?
DISCUSSION QUESTION
What treatment might I get?
6
-
WHAT
TREATMENT
MIGHT
I GET?
Each study medicine will be compared to a placebo.
Different medicines may be tested during the study at the same
time.
6
-
Pills A shot or injection
An infusion
HOW MIGHT
I TAKE THE
STUDY
MEDICINE?
Medicines come in all different forms:
7
• Medicines come in all different forms:• Pills taken by mouth•
A shot or injection• An infusion, which is given slowly through
a
needle into a vein
• After you are put in a treatment group, theresearcher will
give you more information abouthow that study medicine or placebo
is given.
Do you have any questions about the different ways the study
medicine may be given?
DISCUSSION QUESTION
How might I take the study medicine?
7
-
Pills A shot or injection
An infusion
HOW MIGHT
I TAKE THE
STUDY
MEDICINE?
Medicines come in all different forms:
7
-
Tests and health checks
Heart rate
Nose swab
Blood pressure
Blood test
Checkup
Oxygen levels
Saliva test
Deep nose swab
WeightTemperature
WHAT
HAPPENS
AT STUDY
VISITS?
Phase 2: 7 visits2 phone calls
Phase 3: 3 visits5 phone calls
8
• You will have up to 7 visits with a researcherfor tests and up
to 5 phone calls at home withthe researcher or nurse. The number of
visitsor phone calls depends on whether you are inPhase 2 or Phase
3 of the study.
• At the visits, you will have tests and healthchecks to see how
you are doing. You won’thave all of these tests at each visit.
• You will do your own nose swabs at visits and athome. The
study team will teach you how to dothem. You will be asked to write
in your studydiary when you do the swabs.
Do you have any questions about the tests you would have?
DISCUSSION QUESTION
What happens at study visits?
8
-
Tests and health checks
Heart rate
Nose swab
Blood pressure
Blood test
Checkup
Oxygen levels
Saliva test
Deep nose swab
WeightTemperature
WHAT
HAPPENS
AT STUDY
VISITS?
Phase 2: 7 visits2 phone calls
Phase 3: 3 visits5 phone calls
8
-
?WHAT
ARE THE
RISKS AND
BENEFITS?
The study medicine may or may not make you better.
There is a chance for side effects with the study medicine.
Monoclonal antibodies, for example, can cause allergic reactions
and symptoms such as fever, chills, nausea, headache, wheezing,
throat irritation, rash, itch, and dizziness.
Information learned from this study may help others who have
COVID-19.
9
• There are risks to taking part in any clinicalstudy.• It is
not known if the study medicine will work.• The study medicine may
not stop you from
becoming sicker or being hospitalized.• Like with all medicine,
there is also a chance
for side effects. Tell the study team rightaway if you don’t
feel well.
• You may or may not have a direct benefit frombeing in the
study. But information learnedfrom this study may help others who
haveCOVID-19 in the future.
• The informed consent form has moreinformation about possible
risks and benefitsof being in the study. Ask the study team
anyquestions you may have.Do you have any questions about the
possible risks and benefits of being in the study?
DISCUSSION QUESTION
What are the risks and benefits?
9
-
?WHAT
ARE THE
RISKS AND
BENEFITS?
The study medicine may or may not make you better.
There is a chance for side effects with the study medicine.
Monoclonal antibodies, for example, can cause allergic reactions
and symptoms such as fever, chills, nausea, headache, wheezing,
throat irritation, rash, itch, and dizziness.
Information learned from this study may help others who have
COVID-19.
9
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ACTIV-2 Study -Informed Consent - 08-Sep-2020 - V1.0
WHAT
HAPPENS
NEXT?
THANK YOU!
Read the informed consent forms.
Ask questions.
Being in the study is your choice!
• Read the informed consent form and think it over.
• Ask any questions you have about this study atany time.
• Being in the study is your choice. If you joinand then change
your mind, you can stop atany time.
• If you decide to join, you would sign theinformed consent
form.
• Thank you for your time and for consideringtaking part in the
ACTIV-2 Study.
Do you have any other questions about this study?
DISCUSSION QUESTION
What happens next?
10
-
ACTIV-2 Study -Informed Consent -11-Sep-2020 - V1.0
WHAT
HAPPENS
NEXT?
THANK YOU!
Read the informed consent forms.
Ask questions.
Being in the study is your choice!
