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Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

NCT04421664 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-15

No results posted yet for this study

Summary

Study Objective:

To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

Conditions

  • Corona Virus Infection
  • SARS-CoV Infection
  • Coronavirus

Interventions

DRUG

Hydroxychloroquine

200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days

DRUG

Placebo oral tablet

4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days

Sponsors & Collaborators

  • University of Manitoba

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • Eastern Health

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Todd C Lee, MD MPH FIDSA · Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2020-08-17
Completion
2020-08-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT04421664 on ClinicalTrials.gov