Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19 (DAP-CORONA)
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|ClinicalTrials.gov Identifier: NCT04935476|
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : November 24, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Dapsone 85 mg PO BID Drug: Placebo 85 mg PO BID||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
This is a randomized, triple-blind, placebo-controlled, multi-center study.
Following e-signature of the informed consent form, approximately 3000 participants meeting all inclusion criteria and no exclusion criteria will be randomized to receive either Dapsone or placebo (1:1 allocation ratio) for 21 days. Screening blood-work and confirmatory tests are made available to participants at their residence by the study. Study interventions (drugs or placebo) will be delivered directly to participants by courier .
Participants are remotely followed-up through e-daily diary during 21 days of treatment along with virtual visits (phone) at 1, 7, 14, 21, 28 and 51 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events. During study enrollment patients are linked to the study through their participant account on the study virtual care platform.
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Triple (Participant, study staff and data analyst)|
|Official Title:||A Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dapsone for the Treatment of COVID-19 Positive Patients.|
|Actual Study Start Date :||November 22, 2021|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
Active Comparator: Treatment
Participants will receive standard of care and Dapsone per os (PO) twice daily for 21 days. If a dose is missed, it should not be replaced.
Dosage form: Dapsone oral tablet
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.
Other Name: diaminodiphenyl sulfone (DDS)
Placebo Comparator: Control
Participants will receive standard of care and placebo per os (PO) twice daily for 21 days. If a dose is missed, it should not be replaced.
Dosage form: Placebo oral tablet
Drug: Placebo 85 mg PO BID
Placebo oral tablet, twice daily for 21 days.
Other Name: Placebo
- Composite outcome: All cause pre-hospitalization death or all-cause hospitalization [ Time Frame: 30 days post randomization ]Number of participants requiring hospitalization or die prior to hospitalization in the first 30 days after randomization.
- Severe complications (composite outcome: All cause ICU admission, invasive ventilation or pre- or post-hospitalization death) [ Time Frame: 30 days post randomization ]Number of participants developing severe complications and need ICU admission, invasive ventilation or die in the first 30 days.
- All-cause ICU admission [ Time Frame: 30 days post randomization ]Number of participants requiring ICU admission in the first 30 days after randomization.
- Intubation with mechanical ventilation [ Time Frame: 30 days post randomization ]Number of participants requiring intubation with mechanical ventilation in the first 30 days after randomization.
- All-cause death [ Time Frame: 30 days post randomization ]Number of participants who die in the first 30 days after randomization.
- Hospitalization with all-cause requirement of supplemental oxygen [ Time Frame: 30 days post randomization ]Number of participants requiring hospitalization with supplemental oxygen in the first 30 days after randomization.
- Length of hospital stay among participants [ Time Frame: 30 days post randomization ]Duration of hospitalization among study participants requiring hospitalization in the first 30 days after randomization.
- Drug safety (Adverse Event (AE) and Serious Adverse Event (SAE)) for short term therapy in COVID-19 patients [ Time Frame: 30 days post randomization ]Number of participants developing AE and SAE in the first 30 days post randomization.
- Patient reported outcome (e.g. patient reported COVID-19 related symptoms) [ Time Frame: 30 days post randomization ]Trajectory of participant reported COVID-19 related symptoms among study participants in the first 30 days after randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04935476
|Contact: Sharmistha Biswasfirstname.lastname@example.org|
|Contact: María F Sedeñoemail@example.com|
|United States, Arizona|
|Arizona Pulmonary and Medical Specialists||Not yet recruiting|
|Phoenix, Arizona, United States, 85012|
|Contact: Melina Calles Melina.Calles@DignityHealth.org|
|United States, North Carolina|
|Peters Medical Research, LLC||Recruiting|
|High Point, North Carolina, United States, 27262|
|Contact: Anita McPherson firstname.lastname@example.org|
|United States, Pennsylvania|
|Temple University Hospital||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Laurie Jameson email@example.com|
|University of Pittsburgh UPMC||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Joshua Hulbert firstname.lastname@example.org|
|United States, Washington|
|Principle Research Solutions||Recruiting|
|Spokane, Washington, United States, 99204|
|Contact: Christi Witte email@example.com|
|Inspiration Research Limited||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 3A9|
|Contact: Jane Duke firstname.lastname@example.org|
|McGill University Health Centre||Not yet recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Palmina Mancino email@example.com|
|Principal Investigator:||Jean Bourbeau, MD,MSc,FRCPC||RI-MUHC|