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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04935476

Run by

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

People needed

3000

Starts

2021-11-22

Expected to finish

2022-07-31

Last updated by the study team

2022-02-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged ≥ 40 years;
• Symptomatic adults with confirmed COVID-19 (SARS-COV-2 PCR positive) for at least 24 hrs. and no more than 7 days: by report or observation, including one or more of the following: temperature ≥ 38°C (≥100.4°F), chills or shivering, cough, difficulty breathing, fatigue, headache, muscle or body ache, anosmia (loss of smell) and/or dysgeusia (loss of taste), GI symptoms (nausea and/or vomiting);
• (3a) Aged ≥70 years or above, presence of concomitant comorbidity not required for inclusion
• or
• (3b) Aged ≥40 to <70 years, and presence of at least one of the following concomitant comorbidities by report, history, or observation:
• Cardiovascular diseases (e.g., hypertension, coronary artery diseases, congestive heart failure, symptomatic arrhythmia, transient brain ischemia, stroke)
• Chronic respiratory diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD), asthma, pulmonary fibrosis)
• Obesity (BMI >30 kg/m\^2)
• Type 2 Diabetes
• Cancer (participant reported: stable >6 months as per treating doctor/oncologist)
• Autoimmune diseases (T1D, RA, PA, MS, IBD, AD, SS, HT, SLE)
• (4) Participant is considered suitable for continued management in the out-patient setting.
• (5) Non-pregnant non-breastfeeding women of reproductive age group not planning pregnancy and/or adopting advised contraception during the study and for 3 months after the last dose of study medication.

You may not qualify if…

• Unable to provide consent; diagnosis of dementia or other significant neurocognitive disorder;
• Current hospitalization;
• Patient requiring long term oxygen treatment of > 5 L O2/min because of a chronic lung condition at time of recruitment;
• Known intolerance/allergy to sulfone;
• Pregnant or breastfeeding women or is considering becoming pregnant during the study and for 3 months after the last dose of study medication;
• Concurrent malignancy on systemic chemotherapy or immunotherapy;
• Significantly impaired renal function within the past year reported by history and estimated glomerular filtration rate (eGFR) < 60 mL/min at screening
• Severely underweight (≤ 40 kg)
• G6PD deficiency (previous jaundice, jaundice with foods such as beans, or medication such as sulfa drugs, NSAIDs, quinolones, hydroxychloroquine or vitamin C), significant blood dyscrasia or anemia (Hb <12.0 g/dL in women and <13.0 g/dL in men; platelet count <50 x 10\^9/L or < lower limit of normal at screening)
• Impairment liver function [> 2 times the upper limit of normal (ULN) at screening at screening for AST, ALT, ALP, GGT, albumin or bilirubin), liver cirrhosis or hepatitis
• Current use of folic acid antagonists (such as pyrimethamine), nitrofurantoin or primaquine
• Currently taking oral dapsone for dermatological or other indications
• Currently taking hydroxychloroquine or if have taken it within the last 6 months
• Currently on any of the following medications: Aminolevulinic acid; Cladribine; Clozapine; Deferiprone; Prilocaine; Saquinavir; Sodium nitrite, Rifampin or St. John's wort
• Received any of the following vaccines in the last 1 year : Cholera vaccine live; Typhoid vaccine, live; BCG (Bacillus Calmette and Guérin)
• Currently taking any the following anticonvulsants : carbamazepine, phenytoin, levetiracetam and gabapentin
• Currently participating in other interventional trials
• Inability to provide contact details of caregiver/ next of kin to be contacted for study follow-up as participant's surrogate
• Currently taking trimethoprim

Where it is running

• Principle Research Solutions — Spokane, Washington, United States (enrolling)
• Inspiration Research Limited — Toronto, Ontario, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
• Peters Medical Research, LLC — High Point, North Carolina, United States (enrolling)
• University of Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Arizona Pulmonary and Medical Specialists — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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