CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Chloroquine phosphatedrug
Likely dose
Chloroquine phosphate 250mgfrom record
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Search/NCT04328493
NCT04328493Phase 2Completed

A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam

Oxford University Clinical Research Unit, Vietnam·interventional·Posted Mar 31, 2020·Updated May 24, 2021

In Brief

A Phase 2 clinical trial evaluating Chloroquine phosphate for SARS-CoV-2 Infection and COVID-19. Completed, enrolled 10 participants across 5 sites.

Detailed Summary

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.

Study Details

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 31, 2020
Enrollment StartApr 7, 2020
Primary CompletionSep 10, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.3 years ago

Interventions

Chloroquine phosphatedrug

Each chloroquine tablet contains 250mg chloroquine phosphate (or 150mg chloroquine base). Chloroquine treatment for patient is weight-based dosing. Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube. The total duration of treatment with Chloroquine will be 10 days