NCT04935476

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

A Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dapsone for the Treatment of COVID-19 Positive Patients.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to determine whether early treatment with Dapsone reduces pulmonary complications related to COVID-19 and consequent hospitalization in high-risk group of elderly adults and adults (≥40yrs of age) with comorbidity. The secondary objectives are to determine the effect of Dapsone on reducing severe complications related to COVID-19 (ICU, intubation and death) and the safety of treatment with Dapsone in this high-risk COVID-19 patient population. 3000 patients will be enrolled to receive either Dapsone or placebo (1:1 allocation ratio) for 21 days. Follow-up assessments will occur remotely through participant e-daily diary and virtual visits (electronically via internet and/or telephone) at Day 1(start of study drug), 7, 14, 21, 28 and 51 following randomization in order to document the occurrence of any trial endpoints. Safety and efficacy will be based on data from randomized patients. An independent data and safety monitoring committee (DSMC) will periodically review study results and will make recommendations to the study Steering Committee for continuing the trial as planned (or with modification) or for stopping early for safety concerns.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-03-31
• Completion: 2022-07-31
• First posted: 2021-06-23
• Last updated: 2022-02-24

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study