Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis
Status:
Not yet recruiting
Trial end date:
2021-01-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Regional Center for Disease Control and Prevention, Jordan