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

COVID-19 Clinical Trial

— DAP-CORONA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935476
• Other study ID #: PDC01
• Status: Recruiting
• Phase: Phase 3
• Start date: November 22, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Sharmistha Biswas
• Phone: 1-866-327-2728
• Email: sharmistha.biswas[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• Placebo 85 mg PO BID
Placebo oral tablet, twice daily for 21 days.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Pulmonem Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite 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.	30 days post randomization
Secondary	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.	30 days post randomization
Secondary	All-cause ICU admission	Number of participants requiring ICU admission in the first 30 days after randomization.	30 days post randomization
Secondary	Intubation with mechanical ventilation	Number of participants requiring intubation with mechanical ventilation in the first 30 days after randomization.	30 days post randomization
Secondary	All-cause death	Number of participants who die in the first 30 days after randomization.	30 days post randomization
Secondary	Hospitalization with all-cause requirement of supplemental oxygen	Number of participants requiring hospitalization with supplemental oxygen in the first 30 days after randomization.	30 days post randomization
Secondary	Length of hospital stay among participants	Duration of hospitalization among study participants requiring hospitalization in the first 30 days after randomization.	30 days post randomization
Secondary	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.	30 days post randomization
Secondary	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.	30 days post randomization