NCT04935476

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Nov 2021

Geographic Reach
2 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

June 21, 2021

Last Update Submit

February 22, 2022

Conditions

COVID-19

Keywords

DapsoneCOVID-19treatment for COVID-19non-hospitalized patientsprophylaxisSARS-COV-2Clinical trials

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Severe complications (composite outcome: All cause ICU admission, invasive ventilation or pre- or post-hospitalization death)

    30 days post randomization

  • All-cause ICU admission

    30 days post randomization

  • Intubation with mechanical ventilation

    30 days post randomization

  • All-cause death

    30 days post randomization

  • Hospitalization with all-cause requirement of supplemental oxygen

    30 days post randomization

  • +3 more secondary outcomes

Study Arms (2)

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

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

Drug: Placebo 85 mg PO BID

Interventions

Dapsone 85 mg PO BIDDRUG

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.

Also known as: diaminodiphenyl sulfone (DDS)
Treatment
Placebo 85 mg PO BIDDRUG

Placebo oral tablet, twice daily for 21 days.

Also known as: Placebo
Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • (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.

You may not qualify if:

  • 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;
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arizona Pulmonary and Medical Specialists

Phoenix, Arizona, 85012, United States

NOT YET RECRUITING

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

University of Pittsburgh UPMC

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Principle Research Solutions

Spokane, Washington, 99204, United States

RECRUITING

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

DapsoneSDDS

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic Chemicals

Study Officials

  • Jean Bourbeau, MD,MSc,FRCPC

    RI-MUHC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmistha Biswas

CONTACT

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

Duncan Westwood

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, study staff and data analyst)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 23, 2021

Study Start

November 22, 2021

Primary Completion

March 31, 2022

Study Completion

July 31, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)CA(2)