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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,000
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.
Placebo oral tablet, twice daily for 21 days.
Arizona Pulmonary and Medical Specialists
Phoenix, Arizona, United States
NOT_YET_RECRUITINGPeters Medical Research, LLC
High Point, North Carolina, United States
RECRUITINGTemple University Hospital
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGPrinciple Research Solutions
Spokane, Washington, United States
RECRUITINGInspiration Research Limited
Toronto, Ontario, Canada
RECRUITINGMcGill University Health Centre
Montreal, Quebec, Canada
RECRUITINGComposite outcome: All cause pre-hospitalization death or all-cause hospitalization
Number of participants requiring hospitalization or die prior to hospitalization in the first 30 days after randomization.
Time frame: 30 days post randomization
Severe complications (composite outcome: All cause ICU admission, invasive ventilation or pre- or post-hospitalization death)
Number of participants developing severe complications and need ICU admission, invasive ventilation or die in the first 30 days.
Time frame: 30 days post randomization
All-cause ICU admission
Number of participants requiring ICU admission in the first 30 days after randomization.
Time frame: 30 days post randomization
Intubation with mechanical ventilation
Number of participants requiring intubation with mechanical ventilation in the first 30 days after randomization.
Time frame: 30 days post randomization
All-cause death
Number of participants who die in the first 30 days after randomization.
Time frame: 30 days post randomization
Hospitalization with all-cause requirement of supplemental oxygen
Number of participants requiring hospitalization with supplemental oxygen in the first 30 days after randomization.
Time frame: 30 days post randomization
Length of hospital stay among participants
Duration of hospitalization among study participants requiring hospitalization in the first 30 days after randomization.
Time frame: 30 days post randomization
Drug safety (Adverse Event (AE) and Serious Adverse Event (SAE)) for short term therapy in COVID-19 patients
Number of participants developing AE and SAE in the first 30 days post randomization.
Time frame: 30 days post randomization
Patient reported outcome (e.g. patient reported COVID-19 related symptoms)
Trajectory of participant reported COVID-19 related symptoms among study participants in the first 30 days after randomization.
Time frame: 30 days post randomization
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