Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis

Summary

Protocol summary Title A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 Study Periods \& Duration of Treatment Study Duration: 6 months Approval (IRB and regulatory bodies) 1 month Recruitment and follow-up: 3 months Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days, Objectives * To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients. * To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts * To provide early analysis of results and redefine sample size accordingly. * identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III * stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results Design Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following: Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5. Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5. Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.

Timeline

Start

2020-10-27

Primary completion

2021-01-15

Completion

2021-01-31

Drugs

Indications