Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-

controlled prophylaxis study

UK Sample Management v3.0, 2nd July 2020

Laboratory Testing & Sample Processing

EDTA

Plasma

Cell pellet

PK-DBS

Clotted Blood

Serum

Capillary blood

PK-DBS

TNS

(Throat and Nose Swab)

Sputum*

* At this time we are not collectingsputum. You will be informed in future if this situation changes.

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Work-Flow

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Work-Flow (Cont.)

Onset of Covid-19 or ARI

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Sample Management:

This is a screenshot of the sample management system we are using, OpenSpecimen. You will be granted access to this system. It allows us to track the location and number of samples, as well as the dates of collection and other essential data.

If you have any specific queries about this system that aren’t covered in the training manual then please contact the central trial team.

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Sample Management (Cont.)

When you start typing a participant’s ID in the top menu bar it will allow you to click on the participant.

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Sample Management (Cont.)

This page provides access to each collection time point, and you just press collect to start this process.

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Sample Management (Cont.)

This screen allows you to fill in all the necessary information, as well as complete the blood collection data entry in OpenSpecimen.

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Sample Management (Cont.)

This slide shows how toenter a sample’s location inthe storage box.

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Labelling

This is a picture of the labels you will be sent; they contain a round sticker to be placed on the top of the tube and a rectangular one to be placed around the side.

These are pre-printed so all you need to do is affix them.

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Plasma, cell pellet, serum processing

3 vials1 mL serum

3 vials 0.5 mL plasma

1 vial0.5 mL buffy coat

EDTA(store at 4°C)

Serum tube (room temp for 30 mins)

1,500 rcf, 10 minutes, 25 °CNo brake

ImmediateFreezeAt < -80 °C

Invert 6-8 times before processing

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DBS on 31 ET Chr paper for CQ level

Finger prick(D30, D60, D90)

50 µL / spotAir dry6 hr - o/n

Sample Label

• 1 DBS/Bag• Keep in cool ,

dry place• Attach circular

sticker to top right, below seal

No hair

dryer!!

100 µL from EDTA tube BEFORE spin (D0)

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Example for ‘Good’ and ‘Bad’ Quality DBS

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SHIPMENTS• 2 - 5 batches (depends on site facilities, number of samples, etc).

• Shipments will be pre-paid for with Davies International, and samples can be transported 12 or 26 boxes at a time.

• When a collection is requested, a polystyrene box – already filled with dry ice – will be sent to sites for arrival on a Tuesday. Sites will then fill the box, and it will be collected on the same Tuesday for delivery to Oxford (DTU/OCDEM) on Wednesday.

• Sample log data must be sent to the central trial team once shipment organized.

• Davies Int. will apply all the appropriate stickers to the boxes, eg UN3373, UN1845 etc.

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Additional Information

Reference Documents:• COPCOV UK Protocol• COPCOV UK Lab Guidelines and SOP

Always refer to www.copcov.org/sites for correct version of documents

If you have any further questions please contact copcov@dtu.ox.ac.uk