DISulfiram for COvid-19 (DISCO) Trial (DISCO Trial)

Phase 2

Waitlist Available

Led By Sulggi A Lee, MD PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 and day 31

Summary

This trial is testing Disulfiram, a drug used to treat alcohol dependence, to see if it can help people with mild to moderate COVID-19. The drug might work by stopping the virus and reducing inflammation. Disulfiram is an approved oral drug used to treat alcohol use disorder and has shown potential in reducing the incidence and severity of COVID-19.

Eligible Conditions

Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 and day 31

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 and day 31

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and day 31 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.).

Secondary study objectives

Change in COVID-19 Symptom Severity Score as Assessed by a 5-point Adapted Somatic Symptom Severity Score (SSS-8)

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Virologic Impact of 5 Days of Disulfiram, as Measured by the Change in Copies of SARS-CoV-2 Virus Per mL Between Baseline and Day 31.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DisulfiramExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Disulfiram

2008

Completed Phase 4

~1330

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