Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19
NCT ID: NCT04935476
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
3000 participants
INTERVENTIONAL
2021-11-22
2022-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Following e-signature of the informed consent form, approximately 3000 participants meeting all inclusion criteria and no exclusion criteria will be randomized to receive either Dapsone or placebo (1:1 allocation ratio) for 21 days. Screening blood-work and confirmatory tests are made available to participants at their residence by the study. Study interventions (drugs or placebo) will be delivered directly to participants by courier .
Participants are remotely followed-up through e-daily diary during 21 days of treatment along with virtual visits (phone) at 1, 7, 14, 21, 28 and 51 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events. During study enrollment patients are linked to the study through their participant account on the study virtual care platform.
TREATMENT
TRIPLE
Study Groups
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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
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.
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
Placebo 85 mg PO BID
Placebo oral tablet, twice daily for 21 days.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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Pulmonem Inc.
UNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Jean Bourbeau
Principal Investigator
Principal Investigators
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Jean Bourbeau, MD,MSc,FRCPC
Role: PRINCIPAL_INVESTIGATOR
RI-MUHC
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PDC01
Identifier Type: -
Identifier Source: org_study_id
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