Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV)
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...
| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Médium: | Journal article |
| Jazyk: | English |
| Vydáno: |
F1000 Research Ltd
2020
|
| _version_ | 1826310935769251840 |
|---|---|
| author | Schilling, WHK Callery, JJ Taylor, W Mukaka, M Ekkapongpisit, M Watson, JA Chandna, A Panapipat, S Tubprasert, J Yuentrakul, P Waithira, N Cope, T Dhorda, M Cruz, C von Seidlein, L Milton, J LLewelyn, M Adler, A Chotivanich, K Cheah, PY Ashley, EA Mayxay, M Dondorp, AM Phumratanaprapin, W Day, NPJ White, N |
| author_facet | Schilling, WHK Callery, JJ Taylor, W Mukaka, M Ekkapongpisit, M Watson, JA Chandna, A Panapipat, S Tubprasert, J Yuentrakul, P Waithira, N Cope, T Dhorda, M Cruz, C von Seidlein, L Milton, J LLewelyn, M Adler, A Chotivanich, K Cheah, PY Ashley, EA Mayxay, M Dondorp, AM Phumratanaprapin, W Day, NPJ White, N |
| author_sort | Schilling, WHK |
| collection | OXFORD |
| 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 and before infection occurs. We describe the study protocol for a 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 if chloroquine/hydroxychloroquine prophylaxis attenuates severity, prevents asymptomaticCOVID-19 and symptomatic acute respiratory infections of another aetiology (non-SARS-CoV-2). |
| first_indexed | 2024-03-07T08:00:55Z |
| format | Journal article |
| id | oxford-uuid:b5bae1ff-dd2a-4e61-94d4-d81899a3fe7a |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T08:00:55Z |
| publishDate | 2020 |
| publisher | F1000 Research Ltd |
| record_format | dspace |
| spelling | oxford-uuid:b5bae1ff-dd2a-4e61-94d4-d81899a3fe7a2023-09-19T10:36:53ZChloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b5bae1ff-dd2a-4e61-94d4-d81899a3fe7aEnglishSymplectic ElementsF1000 Research Ltd2020Schilling, WHKCallery, JJTaylor, WMukaka, MEkkapongpisit, MWatson, JAChandna, APanapipat, STubprasert, JYuentrakul, PWaithira, NCope, TDhorda, MCruz, Cvon Seidlein, LMilton, JLLewelyn, MAdler, AChotivanich, KCheah, PYAshley, EAMayxay, MDondorp, AMPhumratanaprapin, WDay, NPJWhite, NThere 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 and before infection occurs. We describe the study protocol for a 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 if chloroquine/hydroxychloroquine prophylaxis attenuates severity, prevents asymptomaticCOVID-19 and symptomatic acute respiratory infections of another aetiology (non-SARS-CoV-2). |
| spellingShingle | Schilling, WHK Callery, JJ Taylor, W Mukaka, M Ekkapongpisit, M Watson, JA Chandna, A Panapipat, S Tubprasert, J Yuentrakul, P Waithira, N Cope, T Dhorda, M Cruz, C von Seidlein, L Milton, J LLewelyn, M Adler, A Chotivanich, K Cheah, PY Ashley, EA Mayxay, M Dondorp, AM Phumratanaprapin, W Day, NPJ White, N Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title | Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title_full | Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title_fullStr | Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title_full_unstemmed | Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title_short | Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV) |
| title_sort | chloroquine hydroxychloroquine prevention of coronavirus disease covid 19 in the healthcare setting protocol for a randomised placebo controlled prophylaxis study copcov |
| work_keys_str_mv | AT schillingwhk chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT calleryjj chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT taylorw chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT mukakam chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT ekkapongpisitm chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT watsonja chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT chandnaa chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT panapipats chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT tubprasertj chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT yuentrakulp chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT waithiran chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT copet chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT dhordam chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT cruzc chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT vonseidleinl chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT miltonj chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT llewelynm chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT adlera chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT chotivanichk chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT cheahpy chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT ashleyea chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT mayxaym chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT dondorpam chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT phumratanaprapinw chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT daynpj chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov AT whiten chloroquinehydroxychloroquinepreventionofcoronavirusdiseasecovid19inthehealthcaresettingprotocolforarandomisedplacebocontrolledprophylaxisstudycopcov |