Publication: Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a placebo-controlled prophylaxis study (COPCOV)
Issued Date
2021-01-01
Resource Type
ISSN
2398502X
Other identifier(s)
2-s2.0-85117296728
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Mahidol University
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SCOPUS
Bibliographic Citation
Wellcome Open Research. Vol.5, (2021), 1-21
Suggested Citation
William Hk Schilling, James J. Callery, Walter Taylor, Mavuto Mukaka, Maneerat Ekkapongpisit, James A. Watson, Arjun Chandna, Salwaluk Panapipat, Jaruwan Tubprasert, Prayoon Yuentrakul, Naomi Waithira, Tanya Cope, Mehul Dhorda, Cintia Cruz, Lorenz von Seidlein, Joanne Milton, Martin LLewelyn, Amanda Adler, Kesinee Chotivanich, Phaik Yeong Cheah, Elizabeth A. Ashley, Mayfong Mayxay, Arjen M. Dondorp, Weerapong Phumratanaprapin, Nicholas PJ Day, Nicholas White Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a placebo-controlled prophylaxis study (COPCOV). Wellcome Open Research. Vol.5, (2021), 1-21. doi:10.12688/WELLCOMEOPENRES.15784.1 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/76329
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Title
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a placebo-controlled prophylaxis study (COPCOV)
Author(s)
William Hk Schilling
James J. Callery
Walter Taylor
Mavuto Mukaka
Maneerat Ekkapongpisit
James A. Watson
Arjun Chandna
Salwaluk Panapipat
Jaruwan Tubprasert
Prayoon Yuentrakul
Naomi Waithira
Tanya Cope
Mehul Dhorda
Cintia Cruz
Lorenz von Seidlein
Joanne Milton
Martin LLewelyn
Amanda Adler
Kesinee Chotivanich
Phaik Yeong Cheah
Elizabeth A. Ashley
Mayfong Mayxay
Arjen M. Dondorp
Weerapong Phumratanaprapin
Nicholas PJ Day
Nicholas White
James J. Callery
Walter Taylor
Mavuto Mukaka
Maneerat Ekkapongpisit
James A. Watson
Arjun Chandna
Salwaluk Panapipat
Jaruwan Tubprasert
Prayoon Yuentrakul
Naomi Waithira
Tanya Cope
Mehul Dhorda
Cintia Cruz
Lorenz von Seidlein
Joanne Milton
Martin LLewelyn
Amanda Adler
Kesinee Chotivanich
Phaik Yeong Cheah
Elizabeth A. Ashley
Mayfong Mayxay
Arjen M. Dondorp
Weerapong Phumratanaprapin
Nicholas PJ Day
Nicholas White
Abstract
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).