COVID-19Phase 3DAP-CORONANCT04935476
Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19
A Phase 3 study testing Dapsone 85 mg PO BID in people with COVID-19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Dapsone 85 mg PO BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Nov 2021to 31 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 40 years;
- 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)
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- 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)
- Participant is considered suitable for continued management in the out-patient setting.
- 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.
Who cannot join
- Unable to provide consent; diagnosis of dementia or other significant neurocognitive disorder;
- Current hospitalization;
- Patient requiring long term oxygen treatment of > 5 L O2/min because of a chronic lung condition at time of recruitment;
- Known intolerance/allergy to sulfone;
- Pregnant or breastfeeding women or is considering becoming pregnant during the study and for 3 months after the last dose of study medication;
- Concurrent malignancy on systemic chemotherapy or immunotherapy;
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- Significantly impaired renal function within the past year reported by history and estimated glomerular filtration rate (eGFR) < 60 mL/min at screening
- Severely underweight (≤ 40 kg)
- 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)
- 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
- Current use of folic acid antagonists (such as pyrimethamine), nitrofurantoin or primaquine
- Currently taking oral dapsone for dermatological or other indications
- Currently taking hydroxychloroquine or if have taken it within the last 6 months
- Currently on any of the following medications: Aminolevulinic acid; Cladribine; Clozapine; Deferiprone; Prilocaine; Saquinavir; Sodium nitrite, Rifampin or St. John's wort
- Received any of the following vaccines in the last 1 year : Cholera vaccine live; Typhoid vaccine, live; BCG (Bacillus Calmette and Guérin)
- Currently taking any the following anticonvulsants : carbamazepine, phenytoin, levetiracetam and gabapentin
- Currently participating in other interventional trials
- Inability to provide contact details of caregiver/ next of kin to be contacted for study follow-up as participant's surrogate
- Currently taking trimethoprim
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Peters Medical Research, LLC
High Point, North Carolina, 27262
Sharon Mills, 336-883-9773, sharonm@petersmedicalresearch.com
- Not yet recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Laurie Jameson, laurie.jameson@tuhs.temple.edu
- Not yet recruiting
Arizona Pulmonary and Medical Specialists
Phoenix, Arizona, 85012
Melina Calles, Melina.Calles@DignityHealth.org
- Not yet recruiting
University of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15213
Joshua Hulbert, hulbertjc@upmc.edu
- Recruiting
Principle Research Solutions
Spokane, Washington, 99204
Christi Witte, christi@principleresearchsolutions.com
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Palmina Mancino, palmina.mancino@mcgill.ca
- Recruiting
Inspiration Research Limited
Toronto, Ontario, M5T 3A9
Jane Duke, jduke@inspirationresearch.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Dapsone 85 mg PO BID, Placebo 85 mg PO BID
- Keywords
- Dapsone, COVID-19, treatment for COVID-19, non-hospitalized patients, prophylaxis, SARS-COV-2, Clinical trials
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone 85 mg PO BIDDrug
Also called diaminodiphenyl sulfone (DDS)
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 BIDDrug
Also called Placebo
Placebo oral tablet, twice daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 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 Receives: Drug: Dapsone 85 mg PO BID |
| Control | Placebo comparator | 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 Receives: Drug: Placebo 85 mg PO BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post randomization
Secondary outcomes (8)
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.
Measured: 30 days post randomization
All-cause ICU admission
Number of participants requiring ICU admission in the first 30 days after randomization.
Measured: 30 days post randomization
Intubation with mechanical ventilation
Number of participants requiring intubation with mechanical ventilation in the first 30 days after randomization.
Measured: 30 days post randomization
All-cause death
Number of participants who die in the first 30 days after randomization.
Measured: 30 days post randomization
Hospitalization with all-cause requirement of supplemental oxygen
Number of participants requiring hospitalization with supplemental oxygen in the first 30 days after randomization.
Measured: 30 days post randomization
Length of hospital stay among participants
Duration of hospitalization among study participants requiring hospitalization in the first 30 days after randomization.
Measured: 30 days post randomization
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.
Measured: 30 days post randomization
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.
Measured: 30 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start22 Nov 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, triple-blind, placebo-controlled, multi-center study. 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmonem Inc.
- Responsible party
- Principal investigator, Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jean Bourbeau, MD,MSc,FRCPC, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935476
- Sponsor's protocol ID
- PDC01
- Acronym
- DAP-CORONA
- Status last verified
- Feb 2022
- First submitted
- 21 Jun 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dapsone for the Treatment of COVID-19 Positive Patients.
- ClinicalTrials.gov ID
- NCT04935476
- Acronym / sponsor ID
- DAP-CORONA / PDC01
- Conditions
- COVID-19
- Keywords
- Dapsone, COVID-19, treatment for COVID-19, non-hospitalized patients, prophylaxis, SARS-COV-2, Clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Pulmonem Inc.
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, triple-blind, placebo-controlled, multi-center study. 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Dapsone 85 mg PO BIDParticipants 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 |
| Control | Placebo comparator | Drug: Placebo 85 mg PO BIDParticipants 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female aged ≥ 40 years;
- 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:
Key exclusion criteria (19 listed)
- Unable to provide consent; diagnosis of dementia or other significant neurocognitive disorder;
- Current hospitalization;
- Patient requiring long term oxygen treatment of > 5 L O2/min because of a chronic lung condition at time of recruitment;
- Known intolerance/allergy to sulfone;
- Pregnant or breastfeeding women or is considering becoming pregnant during the study and for 3 months after the last dose of study medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone 85 mg PO BIDAlso: diaminodiphenyl sulfone (DDS)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. | Drug | Treatment |
| Placebo 85 mg PO BIDAlso: PlaceboPlacebo oral tablet, twice daily for 21 days. | Drug | Control |
Primary outcome
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.
8 secondary outcomes
Severe complications (composite outcome: All cause ICU admission, invasive ventilation or pre- or post-hospitalization death)
Time frame: 30 days post randomization
All-cause ICU admission
Time frame: 30 days post randomization
Intubation with mechanical ventilation
Time frame: 30 days post randomization
All-cause death
Time frame: 30 days post randomization
Hospitalization with all-cause requirement of supplemental oxygen
Time frame: 30 days post randomization
Length of hospital stay among participants
Time frame: 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
Patient reported outcome (e.g. patient reported COVID-19 related symptoms)
Time frame: 30 days post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Bourbeau, MD,MSc,FRCPC principal investigator
RI-MUHC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapsone 85 mg PO BID in people with COVID-19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharmistha Biswas (1-866-327-2728, sharmistha.biswas@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome: All cause pre-hospitalization death or all-cause hospitalization (time frame: 30 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.