Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

Summary

The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: * 90 days after enrolment (i.e., completion of kit) * hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or * advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period. This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

Timeline

Start

2020-04-29

Primary completion

2022-03-22

Completion

2022-03-22

Publications

• Winters J, Schilling WH. Approval delays in multi-country COVID-19 trials: the case of COPCOV and the risk of therapeutic inertia. Trials. 2025 Dec 16;27(1):58. doi: 10.1186/s13063-025-09300-z.
• Schilling WHK, Mukaka M, Callery JJ, Llewelyn MJ, Cruz CV, Dhorda M, Ngernseng T, Waithira N, Ekkapongpisit M, Watson JA, Chandna A, Nelwan EJ, Hamers RL, Etyang A, Beg MA, Sow S, Yavo W, Allabi AC, Basnyat B, Sharma SK, Amofa-Sekyi M, Yonga P, Adler A, Yuentrakul P, Cope T, Thaipadungpanit J, Rienpradub P, Imwong M, Abdad MY, Blacksell SD, Tarning J, Goudjo FF, Dossou AD, Konate-Toure A, Assi SB, Ouffoue K, Nasronudin N, Rachman BE, Romadhon PZ, Dewanto DD, Heryana MO, Novi T, Pasaribu AP, Mutiara M, Nasution MPR, Khairunnisa K, Dalimunthe FA, Airlangga E, Fahrezzy A, Subronto Y, Ananda NR, Rahardjani M, Rimainar A, Lucinde RK, Timbwa M, Onyango OE, Agutu C, Akech S, Hamaluba M, Kipyego J, Ngachi O, Haidara FC, Traore OY, Diarra F, Khanal B, Dahal P, Shrestha S, Rijal S, Kabore Y, Adehossi E, Guindo O, Qamar FN, Kazi AM, Woodrow CJ, Laird S, Cheeba M, Ayles H, Cheah PY, Taylor WRJ, Batty EM, Chotivanich K, Pukrittayakamee S, Phumratanaprapin W, von Seidlein L, Dondorp A, Day NPJ, White NJ; COPCOV Collaborative Group. Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial. PLoS Med. 2024 Sep 12;21(9):e1004428. doi: 10.1371/journal.pmed.1004428. eCollection 2024 Sep.
• Kabore Y, Vatrinet R, Guindo O, Moussa SH, Schilling WHK, Grais RF. Reflections on Participation in a Trial on Hydroxychloroquine as Prevention for COVID-19 among Health Workers in Niger. Am J Trop Med Hyg. 2023 Aug 14;109(3):511-514. doi: 10.4269/ajtmh.22-0606. Print 2023 Sep 6.
• Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.

Drugs

Indications