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Publikasi Scopus 2024 per tanggal 30 September 2024 (820 artikel)
Publikasi Scopus 2024 per tanggal 30 September 2024 (820 artikel)
Schilling, William H.K. (57218588758); Mukaka, Mavuto (24465325200); Callery, James J. (57204323594); Llewelyn, Martin J. (57201536091); Cruz, Cintia V. (57223297392); Dhorda, Mehul (56429929800); Ngernseng, Thatsanun (57192832394); Waithira, Naomi (56624485000); Ekkapongpisit, Maneerat (15757195000); Watson, James A. (57202220570); Chandna, Arjun (55749464200); Nelwan, Erni J. (14527452900); Hamers, Raph L. (23034345900); Etyang, Anthony (55308827900); Beg, Mohammad Asim (59329368900); Sow, Sam
Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial
2024
PLoS Medicine
21
9 September
e1004428
0
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85204082070&doi=10.1371%2fjournal.pmed.1004428&partnerID=40&md5=fe178ce0c8e97afd3afb4a62cba2a497
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Department of Global Health and Infection, Brighton and Sussex Medical School, Brighton, United Kingdom; Department of Microbiology and Infection, University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam; Cambodia Oxford Medical Research Unit, Angkor Hospital for Children, Siem Reap, Cambodia; Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Division of Tropical Medicine and Infectious Diseases, Department of Internal Medicine, Dr. Cipto Mangukusumo Hospital, Jakarta, Indonesia; Oxford University Clinical Research Unit Indonesia, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; Department of Pathology and Laboratory Medicine, The Aga Khan University Hospital, Karachi, Pakistan; Centre pour le Développement des Vaccins (CVD-Mali), Bamako, Mali; Centre de Recherche et de Lutte contre le Paludisme, Institut National de Santé Publique, Abidjan, Cote d'Ivoire; Faculty of Health Sciences, Laboratory of Pharmacology and Toxicology, University of Abomey-Calavi, Cotonou, Benin; Oxford University Clinical Research Unit Nepal, Lalitpur, Nepal; B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal; Zambart, University of Zambia School of Public Health, Lusaka, Zambia; Fountain Health Care Hospital, Fountain Projects and Research Office (FOPRO), Eldoret, Kenya; Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Coordination of Allada Ze Toffo Health Zone, Adjian, Benin; National Public Health Laboratory, Cotonou, Benin; Institut Pierre Richet, Institut National de Santé, Publique, Bouake, Cote d'Ivoire; Centre Hospitalier Universitaire (CHU) de Bouaké, Bouake, Cote d'Ivoire; Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia; Universitas Airlangga Teaching Hospital, Universitas Airlangga, Surabaya, Indonesia; Husada Utama Hospital, Surabaya, Indonesia; Faculty of Medicine, Universitas Sumatra Utara, Medan, Indonesia; Murni Teguh Hospital, Medan, Medan, Indonesia; Bunda Thamrin Hospital, Medan, Indonesia; Department of Internal Medicine, Faculty of Medicine, Public Health And Nursing, Universitas Gadjah Mada, Dr. Sardjito Hospital, Yogyakarta, Indonesia; Dr. Sardjito Hospital, Yogyakarta, Indonesia; Epicentre, Niamey, Niger; Université Abdou Moumouni de Niamey, Faculté des Science de la Santé, Niamey, Niger; Department of Paediatrics and Child Health, Aga Khan University Hospital, Karachi, Pakistan; Infectious Diseases Department, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom; University of Oxford, Medical Sciences Division, John Radcliffe Hospital, Oxford, United Kingdom; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, United Kingdom; Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom
Background Hydroxychloroquine (HCQ) has proved ineffective in treating patients hospitalised with Coronavirus Disease 2019 (COVID-19), but uncertainty remains over its safety and efficacy in chemoprevention. Previous chemoprevention randomised controlled trials (RCTs) did not individually show benefit of HCQ against COVID-19 and, although meta-analysis did suggest clinical benefit, guidelines recommend against its use. Methods and findings Healthy adult participants from the healthcare setting, and later from the community, were enrolled in 26 centres in 11 countries to a double-blind, placebo-controlled, randomised trial of COVID-19 chemoprevention. HCQ was evaluated in Europe and Africa, and chloroquine (CQ) was evaluated in Asia, (both base equivalent of 155 mg once daily). The primary endpoint was symptomatic COVID-19, confirmed by PCR or seroconversion during the 3-month follow-up period. The secondary and tertiary endpoints were: asymptomatic laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection; severity of COVID-19 symptoms; all-cause PCR-confirmed symptomatic acute respiratory illness (including SARS-CoV-2 infection); participant reported number of workdays lost; genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity (not reported here); and health economic analyses of HCQ and CQ prophylaxis on costs and quality of life measures (not reported here). The primary and safety analyses were conducted in the intention-to-treat (ITT) population. Recruitment of 40,000 (20,000 HCQ arm, 20,000 CQ arm) participants was planned but was not possible because of protracted delays resulting from controversies over efficacy and adverse events with HCQ use, vaccine rollout in some countries, and other factors. Between 29 April 2020 and 10 March 2022, 4,652 participants (46% females) were enrolled (HCQ/CQ n = 2,320; placebo n = 2,332). The median (IQR) age was 29 (23 to 39) years. SARS-CoV-2 infections (symptomatic and asymptomatic) occurred in 1,071 (23%) participants. For the primary endpoint the incidence of symptomatic COVID-19 was 240/ 2,320 in the HCQ/CQ versus 284/2,332 in the placebo arms (risk ratio (RR) 0.85 [95% confidence interval, 0.72 to 1.00; p = 0.05]). For the secondary and tertiary outcomes asymptomatic SARS-CoV-2 infections occurred in 11.5% of HCQ/CQ recipients and 12.0% of placebo recipients: RR: 0.96 (95% CI, 0.82 to 1.12; p = 0.6). There were no differences in the severity of symptoms between the groups and no severe illnesses. HCQ/CQ chemoprevention was associated with fewer PCR-confirmed all-cause respiratory infections (predominantly SARS-CoV-2): RR 0.61 (95% CI, 0.42 to 0.88; p = 0.009) and fewer days lost to work because of illness: 104 days per 1,000 participants over 90 days (95% CI, 12 to 199 days; p < 0.001). The prespecified meta-analysis of all published pre-exposure RCTs indicates that HCQ/CQ prophylaxis provided a moderate protective benefit against symptomatic COVID-19: RR 0.80 (95% CI, 0.71 to 0.91). Both drugs were well tolerated with no drug-related serious adverse events (SAEs). Study limitations include the smaller than planned study size, the relatively low number of PCR-confirmed infections, and the lower comparative accuracy of serology endpoints (in particular, the adapted dried blood spot method) compared to the PCR endpoint. The COPCOV trial was registered with ClinicalTrials.gov; number NCT04303507. Interpretation In this large placebo-controlled, double-blind randomised trial, HCQ and CQ were safe and well tolerated in COVID-19 chemoprevention, and there was evidence of moderate protective benefit in a meta-analysis including this trial and similar RCTs. Copyright: © 2024 Schilling 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 author and source are credited.
Adult; Antiviral Agents; Chloroquine; COVID-19; COVID-19 Drug Treatment; Double-Blind Method; Female; Humans; Hydroxychloroquine; Male; Middle Aged; SARS-CoV-2; Treatment Outcome; Young Adult; chloroquine; cholesterol; hydroxychloroquine; immunosuppressive agent; antivirus agent; chloroquine; hydroxychloroquine; abdominal pain; acquired immune deficiency syndrome; adult; anosmia; arthralgia; Article; asthma; blood sampling; body height; body mass; body weight; chronic kidney failure; chronic lung disease; clinical trial; controlled study; coronavirus disease 2019; coughing; diabetes mellitus; diarrhea; disease severity; dizziness; double blind procedure; drug efficacy; drug safety; drug screening; drug tolerability; dyspnea; fatigue; female; fever; headache; health care access; human; hype
Wellcome Trust, WT, (221307/Z/20/Z); Wellcome Trust, WT
This research was funded by the Wellcome Trust [Grant number 221307/Z/20/Z] through the COVID-19 Therapeutics Accelerator.
Public Library of Science
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39264960
Article
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