The Vietnam Chloroquine Treatment on COVID-19

NCT04328493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-05-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Chloroquine phosphate

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

Sponsors & Collaborators

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER
  • Ministry of Health, Vietnam

    collaborator OTHER_GOV
  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER
  • Cu Chi COVID Hospital, Vietnam

    collaborator UNKNOWN
  • Can Gio COVID Hospital, Vietnam

    collaborator UNKNOWN
  • Cho Ray Hospital

    collaborator OTHER
  • National Hospital for Tropical Diseases, Hanoi, Vietnam

    collaborator OTHER_GOV
  • Department of Health, Ho Chi Minh city

    collaborator UNKNOWN

Principal Investigators

  • Guy Thwaites, PhD. MD · University of Oxford, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-07
Primary Completion
2020-09-10
Completion
2020-09-10

Countries

  • Vietnam

Study Locations

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Entities

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 NCT04328493 on ClinicalTrials.gov