Recruiting
Phase 3

Dapsone

Sponsor:

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

Code:

NCT04935476

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Dapsone 85 mg PO BID

Placebo 85 mg PO BID

Study Details

Brief 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.

Conditions

COVID-19

Study ID

NCT04935476

Start date

Nov 22, 2021

Status verified date

Feb, 2022

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female aged ≥ 40 years;
2. 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.

Exclusion Criteria:

1. Unable to provide consent; diagnosis of dementia or other significant neurocognitive disorder;
2. Current hospitalization;
3. Patient requiring long term oxygen treatment of > 5 L O2/min because of a chronic lung condition at time of recruitment;
4. Known intolerance/allergy to sulfone;
5. Pregnant or breastfeeding women or is considering becoming pregnant during the study and 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 and estimated 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 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)
10. 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
11. Current use of folic acid antagonists (such as pyrimethamine), nitrofurantoin or primaquine
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's wort
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 for study follow-up as participant's surrogate
19. Currently taking trimethoprim

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

Placebo 85 mg PO BID

Placebo oral tablet, twice daily for 21 days.

Primary outcome measure

  • Composite outcome: All cause pre-hospitalization death or all-cause hospitalization [ Time Frame: 30 days post randomization ]

Central Contacts and Locations

Locations

Peters Medical Research, LLC

Recruiting

High Point, North Carolina, United States, 27262

Contacts

Principle Research Solutions

Recruiting

Spokane, Washington, United States, 99204

Contacts

Inspiration Research Limited

Recruiting

Toronto, Ontario, Canada, M5T 3A9

Contacts

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

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

Last update posted

Feb 24, 2022

Last verified

Feb, 2022

Keywords

  • Dapsone
  • COVID-19
  • treatment for COVID-19
  • non-hospitalized patients
  • prophylaxis
  • SARS-COV-2
  • Clinical trials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2022-02-24.