Status:
TERMINATED
DISulfiram for COvid-19 (DISCO) Trial
Lead Sponsor:
University of California, San Francisco
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have ...
Detailed Description
The identification of a safe, effective treatment for individuals with early mild-to-moderate symptomatic COVID-19 that prevent progression to more severe disease would have immediate public health im...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent, and
- Age \>= 18 years, and
- SARS-CoV-2 positive PCR (nucleic acid) test within the preceding 7 days, and
- Not currently hospitalized, and
- Willing to abstain from any alcohol during the two week period in which disulfiram will be administered and during the two week period immediately after disulfiram administration.
- Both male and female subjects are eligible. Females of childbearing potential must have a negative pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
Exclusion
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months
- Decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice
- Serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment
- Concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon-alpha, methotrexate, cancer chemotherapy). NOTE: use of inhaled or nasal steroid is not exclusionary.
- Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
- Current alcohol use disorder or hazardous alcohol use (\>7 drinks per week for women or \> 14 drinks per week for men) as determined by clinical evaluation.
- Current use of any drug formulation that contains alcohol or that might contain alcohol
- Current use of warfarin.
- Clinically active hepatitis determined by the study physician; ALT or AST \> 3 x the upper limit of normal or total bilirubin outside the normal range.
- Allergy to rubber or thiuram derivatives
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04485130
Start Date
August 18 2021
End Date
February 28 2022
Last Update
September 13 2023
Active Locations (2)
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1
University of California San Francisco, Fresno
Fresno, California, United States, 93701
2
San Francisco General Hospital
San Francisco, California, United States, 94110