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

February 22, 2022 updated by: Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh UPMC
        • Contact:
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • diaminodiphenyl sulfone (DDS)
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
Drug: Placebo 85 mg PO BID
Placebo oral tablet, twice daily for 21 days.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome: All cause pre-hospitalization death or all-cause hospitalization
Time Frame: 30 days post randomization
Number of participants requiring hospitalization or die prior to hospitalization in the first 30 days after randomization.
30 days post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe complications (composite outcome: All cause ICU admission, invasive ventilation or pre- or post-hospitalization death)
Time Frame: 30 days post randomization
Number of participants developing severe complications and need ICU admission, invasive ventilation or die in the first 30 days.
30 days post randomization
All-cause ICU admission
Time Frame: 30 days post randomization
Number of participants requiring ICU admission in the first 30 days after randomization.
30 days post randomization
Intubation with mechanical ventilation
Time Frame: 30 days post randomization
Number of participants requiring intubation with mechanical ventilation in the first 30 days after randomization.
30 days post randomization
All-cause death
Time Frame: 30 days post randomization
Number of participants who die in the first 30 days after randomization.
30 days post randomization
Hospitalization with all-cause requirement of supplemental oxygen
Time Frame: 30 days post randomization
Number of participants requiring hospitalization with supplemental oxygen in the first 30 days after randomization.
30 days post randomization
Length of hospital stay among participants
Time Frame: 30 days post randomization
Duration of hospitalization among study participants requiring hospitalization in the first 30 days after randomization.
30 days post randomization
Drug safety (Adverse Event (AE) and Serious Adverse Event (SAE)) for short term therapy in COVID-19 patients
Time Frame: 30 days post randomization
Number of participants developing AE and SAE in the first 30 days post randomization.
30 days post randomization
Patient reported outcome (e.g. patient reported COVID-19 related symptoms)
Time Frame: 30 days post randomization
Trajectory of participant reported COVID-19 related symptoms among study participants in the first 30 days after randomization.
30 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Pulmonem Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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