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Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

NCT04303507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4652

Last updated 2023-04-04

No results posted yet for this study

Summary

The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites.

The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.

If the participant is diagnosed with COVID-19, they will take continue to take the study medication until:

* 90 days after enrolment (i.e., completion of kit)
* hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or
* advised to stop by their healthcare professional for other reasons

Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

Conditions

  • COVID19
  • Coronavirus
  • Acute Respiratory Illnesses

Interventions

DRUG

Chloroquine or Hydroxychloroquine

A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • William Schilling, MD · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2022-03-22
Completion
2022-03-22

Countries

  • Benin
  • Côte d’Ivoire
  • Indonesia
  • Kenya
  • Mali
  • Nepal
  • Pakistan
  • Thailand
  • United Kingdom
  • Zambia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04303507 on ClinicalTrials.gov