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

Last updated: February 22, 2022
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04935476
PDC01
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged ≥ 40 years;
  2. Symptomatic adults with confirmed COVID-19 (SARS-COV-2 PCR positive) for at least 24hrs. and no more than 7 days: by report or observation, including one or more of thefollowing: temperature ≥ 38°C (≥100.4°F), chills or shivering, cough, difficultybreathing, fatigue, headache, muscle or body ache, anosmia (loss of smell) and/ordysgeusia (loss of taste), GI symptoms (nausea and/or vomiting);

(3a) Aged ≥70 years or above, presence of concomitant comorbidity not required forinclusion or

(3b) Aged ≥40 to <70 years, and presence of at least one of the following concomitantcomorbidities by report, history, or observation:

  • Cardiovascular diseases (e.g., hypertension, coronary artery diseases, congestiveheart 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-patientsetting. (5) Non-pregnant non-breastfeeding women of reproductive age group not planningpregnancy and/or adopting advised contraception during the study and for 3 monthsafter the last dose of study medication.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 3000
Study Start date:
November 22, 2021
Estimated Completion Date:
July 31, 2022

Study 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.

Connect with a study center

  • Inspiration Research Limited

    Toronto, Ontario M5T 3A9
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Arizona Pulmonary and Medical Specialists

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • The Lundquist Institute At Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Florida Lung Specialists

    Kissimmee, Florida 34746
    United States

    Site Not Available

  • University of Miami-Miller School of Medicine

    Miami, Florida 33101
    United States

    Site Not Available

  • Peters Medical Research, LLC

    High Point, North Carolina 27262
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Pittsburgh UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Principle Research Solutions

    Spokane, Washington 99204
    United States

    Active - Recruiting

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