Official Title
A Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dapsone for the Treatment of COVID-19 Positive Patients.
Brief Summary

This is a multi-center, randomized, triple-blind, placebo-controlled (RCT) study toevaluate 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 confirmedSARS-CoV-2 infection.3000 infected patients diagnosed with COVID-19, non-hospitalized at the time ofenrollment, meeting all inclusion and no exclusion criteria will be randomized (1:1allocation ratio) to receive either Dapsone or placebo tablets for 21 days, and will befollowed up for 7 days after treatment termination for outcome assessment and up to 30days for safety monitoring.

Detailed 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.

Unknown status
COVID-19

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)

Drug: Placebo 85 mg PO BID

Placebo oral tablet, twice daily for 21 days.
Other Name: Placebo

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: N/A
Countries
Canada
United States
Locations

Arizona Pulmonary and Medical Specialists
Phoenix, Arizona, United States

Peters Medical Research, LLC
High Point, North Carolina, United States

Temple University Hospital
Philadelphia, Pennsylvania, United States

University of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States

Principle Research Solutions
Spokane, Washington, United States

Inspiration Research Limited
Toronto, Ontario, Canada

McGill University Health Centre
Montreal, Quebec, Canada

Contacts

Sharmistha Biswas
1-866-327-2728
sharmistha.biswas@mail.mcgill.ca

Duncan Westwood
1-866-327-2728
duncan.westwood@muhc.mcgill.ca

Jean Bourbeau, MD,MSc,FRCPC, Principal Investigator
RI-MUHC

Pulmonem Inc.
NCT Number
Keywords
Dapsone
Covid-19
Treatment for COVID-19
non-hospitalized patients
prophylaxis
SARS-CoV-2
Clinical Trials
MeSH Terms
COVID-19
Dapsone