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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a placebo-controlled prophylaxis study (COPCOV)
Wellcome Open Research, Volume 5, Year 2021
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Description
There is no proven preventative therapy or vaccine against COVID-19. Theinfection has spread rapidly and there has already been a substantial adverse impact on the global economy. Healthcare workers have been affected disproportionately in the continuing pandemic. Significant infection rates in this critical group have resulted in a breakdown of health services in some countries. Chloroquine, and the closely related hydroxychloroquine, are safe and well tolerated medications which can be given for years without adverse effects. Chloroquine and hydroxychloroquine have significant antiviral activity against SARS-CoV-2, and despite the lack of benefit of hydroxychloroquine treatment in patients hospitalised with severe COVID-19, these drugs could still work in prevention. The emerging infection paradigm of an early viral peak, and late inflammation where there is benefit from corticosteroids. If these direct actiing antivirals are to work, they have the best chance given either early in infection infection occurs. We describe the study protocol for multi-centre, multi-country randomised, double blind, placebo controlled trial to answer the question can chloroquine/ hydroxychloroquine prevent COVID-19. 40,000 participants working in healthcare facilities or involved in the management of COVID-19 will be randomised 1:1 to receive chloroquine/ hydroxychloroquine or matched placebo as daily prophylaxis for three months. The primary objective is the prevention of symptomatic, virological or serologically proven coronavirus disease (COVID-19). The study could detect a 23% reduction from an incidence of 3% in the placebo group for either drug with 80% power. Secondary objectives are to determine ifchloroquine/hydroxychloroquine prophylaxis attenuates severity, prevents asymptomaticCOVID-19 and symptomatic acute respiratory infections of another aetiology (non-SARS-CoV-2). © 2020. Schilling WH et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Authors & Co-Authors
Schilling, William H.K.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Callery, James John
Thailand, Nakhon Pathom
Mahidol University
Taylor, Walter Robert John
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Mukaka, Mavuto F.J.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Watson, James A.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Chandna, Arjun
United Kingdom, Oxford
University of Oxford
Yuentrakul, Prayoon
Thailand, Nakhon Pathom
Mahidol University
Waithira, Naomi
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Dhorda, M. J.
Thailand, Nakhon Pathom
Mahidol University
Von-Seidlein, Lorenz
Thailand, Nakhon Pathom
Mahidol University
Milton, Joanne E.
Unknown Affiliation
Llewelyn, Martin J.
United Kingdom, Brighton
Brighton and Sussex Medical School
Chotivanich, Kesinee T.
Thailand, Nakhon Pathom
Mahidol University
Cheah, Phaikyeong
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Ashley, Elizabeth A.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Thailand
Mahosot Hospital, Lao
Mayxay, Mayfong
Thailand
Mahosot Hospital, Lao
Dondorp, Arjen M.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Phumratanaprapin, Weerapong
Thailand, Nakhon Pathom
Mahidol University
White, Nicholas John
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
University of Oxford
Statistics
Citations: 1
Authors: 19
Affiliations: 4
Identifiers
Doi:
10.12688/WELLCOMEOPENRES.15784.1
ISSN:
2398502X
Research Areas
Covid
Disability
Health System And Policy
Study Design
Cohort Study