drugset / Trial / NCT04935476
Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19
Phase 3
Unknown
3000 enrolled
McGill University Health Centre/Research Institute of the McGill University Health Centre
Pulmonem Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-11-22
- Primary completion
- 2022-03-31
- Completion
- 2022-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapsone | Small molecule | 85 mg | Oral |