TY - JOUR
T1 - Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a placebo-controlled prophylaxis study (COPCOV)
AU - Schilling, William Hk
AU - Callery, James J.
AU - Taylor, Walter
AU - Mukaka, Mavuto
AU - Ekkapongpisit, Maneerat
AU - Watson, James A.
AU - Chandna, Arjun
AU - Panapipat, Salwaluk
AU - Tubprasert, Jaruwan
AU - Yuentrakul, Prayoon
AU - Waithira, Naomi
AU - Cope, Tanya
AU - Dhorda, Mehul
AU - Cruz, Cintia
AU - von Seidlein, Lorenz
AU - Milton, Joanne
AU - LLewelyn, Martin
AU - Adler, Amanda
AU - Chotivanich, Kesinee
AU - Cheah, Phaik Yeong
AU - Ashley, Elizabeth A.
AU - Mayxay, Mayfong
AU - Dondorp, Arjen M.
AU - Phumratanaprapin, Weerapong
AU - Day, Nicholas P. J.
AU - White, Nicholas
N1 - Funding Information: Grant information: This study is funded via the COVID-19 Therapeutics Accelerator (Bill & Melinda Gates Foundation, Mastercard and the Wellcome Trust). Publisher Copyright: © 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.
PY - 2021
Y1 - 2021
N2 - 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).
AB - 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).
KW - COVID-19
KW - SARSCoV-2
KW - acute respiratory illness
KW - chloroquine
KW - coronavirus
KW - prophylaxis
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85166134922&origin=inward
U2 - https://doi.org/10.12688/WELLCOMEOPENRES.15784.1
DO - https://doi.org/10.12688/WELLCOMEOPENRES.15784.1
M3 - Article
SN - 2398-502X
VL - 5
SP - 1
EP - 21
JO - Wellcome open research
JF - Wellcome open research
ER -