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

Page created by Barbara Klein
 
CONTINUE READING
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
Laboratory Testing & Sample
                  Processing

              Clotted            Capillary       TNS
EDTA                                           (Throat and         Sputum*
               Blood              blood
                                               Nose Swab)

 Plasma         Serum                 PK-DBS

Cell pellet

 PK-DBS                                                      * At this time we are not collecting
                                                             sputum. You will be informed in
                                                             future if this situation changes.

                        V3.0, 02 July 2020                                                          2
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
Work-Flow

            V3.0, 02 July 2020   3
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
Work-Flow (Cont.)
Onset of Covid-19 or ARI

                           V3.0, 02 July 2020   4
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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.

                                               V3.0, 02 July 2020                        5
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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.

                                       V3.0, 02 July 2020              6
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
Sample Management (Cont.)

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

                                     V3.0, 02 July 2020                  7
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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.

               V3.0, 02 July 2020               8
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
Sample Management (Cont.)

                                    This slide shows
                                    how to
                                    enter a
                                    sample’s
                                    location in
                                    the storage box.

               V3.0, 02 July 2020              9
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled ...
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.

                                        V3.0, 02 July 2020                              10
Plasma, cell pellet, serum processing
                 Invert 6-8
               times before                        3 vials
     EDTA       processing                         0.5 mL plasma
     (store
     at 4°C)                                       1 vial
                                                   0.5 mL buffy
                1,500 rcf,                         coat            Immediate
                10 minutes,                                        Freeze
    Serum       25 °C                                              At < -80 °C
    tube        No brake
                                                   3 vials
    (room
                                                   1 mL serum
    temp for
    30 mins)

                              V3.0, 02 July 2020                                 11
DBS on 31 ET Chr paper for CQ level
                                                     Sample Label
   100 µL
   from EDTA
   tube
   BEFORE
   spin (D0)                                                        • 1 DBS/Bag
                                                      Air dry
                 50 µL / spot                         6 hr - o/n    • Keep in cool ,
                                                                      dry place
    Finger                                                          • Attach circular
    prick
                                                          No          sticker to top
    (D30, D60,
    D90)                                                 hair         right, below
                                                        dryer!!       seal

                                V3.0, 02 July 2020                                 12
Example for ‘Good’ and ‘Bad’ Quality DBS

                 V3.0, 02 July 2020   13
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.

                                      V3.0, 02 July 2020                              14
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

                               V3.0, 02 July 2020                      15
You can also read