DISulfiram for COvid-19 (DISCO) Trial (DISCO)
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ClinicalTrials.gov Identifier: NCT04485130 |
Recruitment Status :
Suspended
(Low COVID case numbers, competing COVID treatments available)
First Posted : July 24, 2020
Last Update Posted : May 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Disulfiram Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | This is a dose escalation double blind randomized (2:1) placebo-controlled trial of disulfiram given as 1000 mg/day x 5 consecutive days (Cohort 1: N=20 drug/N=10 placebo) or 2000 mg/day x 5 consecutive days (Cohort 2: N=20 drug/N=10 placebo) among 60 acute symptomatic lab-confirmed (<7 days) COVID+ individuals . |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double blind |
Primary Purpose: | Treatment |
Official Title: | DISulfiram for COvid-19 (DISCO) Trial: A Phase 2 Double-Blind, Randomized Placebo-Controlled Trial of Disulfiram Compared to Standard Care in Patients With Symptomatic COVID-19 |
Actual Study Start Date : | May 1, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | April 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Disulfiram
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
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Drug: Disulfiram
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
Other Name: Antabuse |
Placebo Comparator: Placebo
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
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Drug: Placebo
This study will provide placebo. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days |
- Immunologic impact of 5 days of disulfiram, as measured by the fold-change in plasma levels of pro-inflammatory cytokines (e.g, interleukin 6, interleukin 1-beta, etc.). [ Time Frame: 31 days ]Change in plasma inflammatory biomarker levels (e.g., IL-6, IL-1b) at days 5, 15, and 31.
- Virologic impact of 5 days of disulfiram, as measured by the fold-change in copies of SARS-CoV-2 virus per million cells between Baseline and Day 31. [ Time Frame: 31 days ]Change in SARS-CoV-2 PCR quantitative viral load at days 5, 15, and 31
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 31 days ]The safety and tolerability of a 5 day course of disulfiram. The number of adverse events and their grade will be determined for each participant.
- Change in COVID-19 symptom severity score as assessed by a 5-point adapted somatic symptom severity score (SSS-8) [ Time Frame: 31 days ]The severity of COVID-19 symptoms will be recorded on a 5-point symptom severity scale at each visit for each participant.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485130
United States, California | |
University of California San Francisco, Fresno | |
Fresno, California, United States, 93701 | |
San Francisco General Hospital | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Sulggi A Lee, MD PhD | University of California, San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sulggi A. Lee, MD, PhD, Associate Professor of Medicine, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04485130 |
Other Study ID Numbers: |
DSF151837 |
First Posted: | July 24, 2020 Key Record Dates |
Last Update Posted: | May 2, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Planned sharing of de-identified individual participant data for the purposes of collaboration and meta-analyses. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | After publication of study results |
Access Criteria: | De-identified data |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Disulfiram COVID-19 SARS-CoV-2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Disulfiram Alcohol Deterrents Acetaldehyde Dehydrogenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |