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

NCT04597775 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

  • SARS-CoV Infection

Interventions

DRUG

hydroxychloroquine

hydroxychloroquine

Sponsors & Collaborators

  • Farhat Hached Hospital, Tunisia

    collaborator UNKNOWN

  • Fattouma Bourguiba, Tunisia

    collaborator UNKNOWN

  • Regional Center for Disease Control and Prevention, Jordan

    lead OTHER

Principal Investigators

  • Munir Abu-Helalah, PHD · Regional Center for Disease Control

  • Wissem Hachfi, MD · Farhat Hached Hospital, Tunisia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2021-01-15
Completion
2021-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597775 on ClinicalTrials.gov