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Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19

NCT04935476 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2022-02-24

No results posted yet for this study

Summary

This is a multi-center, randomized, triple-blind, placebo-controlled (RCT) study to evaluate the efficacy and safety of Dapsone in older adults, and/or in adult patients (≥40yrs of age) with at least one high-risk comorbidity, among those with confirmed SARS-CoV-2 infection.

3000 infected patients diagnosed with COVID-19, non-hospitalized at the time of enrollment, meeting all inclusion and no exclusion criteria will be randomized (1:1 allocation ratio) to receive either Dapsone or placebo tablets for 21 days, and will be followed up for 7 days after treatment termination for outcome assessment and up to 30 days for safety monitoring.

Conditions

Interventions

DRUG

Dapsone 85 mg PO BID

Participants will receive standard of care and study medication Dapsone 85 mg per os (PO) twice daily for 21 days. If a dose is missed, it will not be replaced.

DRUG

Placebo 85 mg PO BID

Placebo oral tablet, twice daily for 21 days.

Sponsors & Collaborators

  • Pulmonem Inc.

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Jean Bourbeau, MD,MSc,FRCPC · RI-MUHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2022-03-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04935476 on ClinicalTrials.gov