CovidResearchTrials by Shray Alag


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DisulfiramWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Correlated MeSH Terms (1)


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D059350 Chronic Pain NIH 0.35

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0012532 Chronic pain HPO 0.35

There is one clinical trial.

Clinical Trials


1 Virologic and Immunologic Response to Disulfiram in Early Symptomatic COVID+ Outpatients

Disulfiram 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 both antiviral (inhibiting viral replication via blocking the Mpro protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will test disulfiram 2000 mg/day for 3 consecutive days (doses shown to be well tolerated and safe in a recent phase 2b trial) in 60 symptomatic COVID PCR+ individuals in a randomized (1:1) clinical trial evaluating the effect on COVID symptoms severity, SARS-CoV-2 viral load, and biomarkers of inflammation over 31 days.

NCT04485130 Covid19 Drug: Disulfiram Drug: Placebo

Primary Outcomes

Description: The safety and tolerability of a 3 day course of disulfiram. The number of adverse events and their grade will be determined for each participant.

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time: 31 days

Description: The severity of COVID-19 symptoms will be recorded on a 5-point symptom severity scale at each visit for each participant.

Measure: Change in COVID-19 symptom severity score as assessed by a 5-point adapted somatic symptom severity score (SSS-8)

Time: 31 days

Secondary Outcomes

Description: Quantitative SARS-CoV-2 viral load measures will be determined at each visit for each participant.

Measure: Virologic impact of 3 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: 31 days

Description: High sensitivity plasma cytokine measures for interleukin 6, interleukin 1-beta, and other pro-inflammatory cytokines will be determined at each visit for each participant.

Measure: Immunologic impact of 3 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: 31 days


No related HPO nodes (Using clinical trials)