Phase
Condition
Covid-19
Treatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female aged ≥ 40 years;
- Symptomatic adults with confirmed COVID-19 (SARS-COV-2 PCR positive) for at least 24hrs. and no more than 7 days: by report or observation, including one or more of thefollowing: temperature ≥ 38°C (≥100.4°F), chills or shivering, cough, difficultybreathing, fatigue, headache, muscle or body ache, anosmia (loss of smell) and/ordysgeusia (loss of taste), GI symptoms (nausea and/or vomiting);
(3a) Aged ≥70 years or above, presence of concomitant comorbidity not required forinclusion or
(3b) Aged ≥40 to <70 years, and presence of at least one of the following concomitantcomorbidities by report, history, or observation:
- Cardiovascular diseases (e.g., hypertension, coronary artery diseases, congestiveheart 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-patientsetting. (5) Non-pregnant non-breastfeeding women of reproductive age group not planningpregnancy and/or adopting advised contraception during the study and for 3 monthsafter the last dose of study medication.
Exclusion
Exclusion Criteria:
- Unable to provide consent; diagnosis of dementia or other significant neurocognitivedisorder;
- Current hospitalization;
- Patient requiring long term oxygen treatment of > 5 L O2/min because of a chronic lungcondition at time of recruitment;
- Known intolerance/allergy to sulfone;
- Pregnant or breastfeeding women or is considering becoming pregnant during the studyand 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 andestimated glomerular filtration rate (eGFR) < 60 mL/min at screening
- Severely underweight (≤ 40 kg)
- G6PD deficiency (previous jaundice, jaundice with foods such as beans, or medicationsuch as sulfa drugs, NSAIDs, quinolones, hydroxychloroquine or vitamin C), significantblood dyscrasia or anemia (Hb <12.0 g/dL in women and <13.0 g/dL in men; plateletcount <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 atscreening for AST, ALT, ALP, GGT, albumin or bilirubin), liver cirrhosis or hepatitis
- Current use of folic acid antagonists (such as pyrimethamine), nitrofurantoin orprimaquine
- 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'swort
- 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 forstudy follow-up as participant's surrogate
- Currently taking trimethoprim
Study Design
Study Description
Connect with a study center
Inspiration Research Limited
Toronto, Ontario M5T 3A9
CanadaActive - Recruiting
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Arizona Pulmonary and Medical Specialists
Phoenix, Arizona 85012
United StatesSite Not Available
The Lundquist Institute At Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Florida Lung Specialists
Kissimmee, Florida 34746
United StatesSite Not Available
University of Miami-Miller School of Medicine
Miami, Florida 33101
United StatesSite Not Available
Peters Medical Research, LLC
High Point, North Carolina 27262
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
University of Pittsburgh UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Principle Research Solutions
Spokane, Washington 99204
United StatesActive - Recruiting
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