The Vietnam Chloroquine Treatment on COVID-19

• Status: Completed
• Trial end date: 2020-09-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborators: Can Gio COVID Hospital, Vietnam; Cho Ray Hospital; Cho Ray Hospital, Vietnam; Cu Chi COVID Hospital, Vietnam; Department of Health, Ho Chi Minh city; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Ministry of Health, Vietnam; National Hospital for Tropical Diseases, Hanoi, Vietnam
• Treatments: Chloroquine; Chloroquine diphosphate

Criteria

1. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician.

2. Provides written informed consent prior to initiation of any study procedures (or legally authorized representative).

3. Understands and agrees to comply with planned study procedures.

4. Agrees to the collection of OP swabs and venous blood per protocol.

5. Male or female adult ≥18 years of age at time of enrollment.