CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


SOC + PlaceboWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug2164 SOC + Intravenous Famotidine Wiki 1.00
drug1150 IMU-838 Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Multi-site, Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Standard of Care (SOC) Plus Famotidine vs SOC Plus Placebo for the Treatment of COVID-19 in Hospitalized Adults

The overall objective of the study is to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients hospitalized and meeting radiologic criteria for COVID-19 disease. SOC for the treatment for COVID-19 has evolved since the initial conceptualization of this protocol and early recruitment of patients. Initially SOC included hydroxychloroquine and has progressed to include Remdesivir. This protocol is amended to allow the SOC to reflect the prevailing treatment for COVID-19. We will compare clinical outcomes associated with SOC and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 471 COVID-19 patients hospitalized with moderate to severe disease into each of the two treatment arms, with a total enrollment target of at least 942 patients. This trial has been designed and powered to support up to three interim analyses that will enable prompt assessment of benefits and risks of the two treatment groups while maintaining the rigorous gold standard of a randomized double blind clinical trial structure. Trial design has been guided by practical consideration of the current clinical context involving rapidly escalating demands on hospital staff and resources, and incorporates a minimalist approach employing existing laboratory information management systems and a clinically relevant binary primary outcome of 30-day endpoint of death or survival.

NCT04370262 COVID-19 Drug: SOC + Intravenous Famotidine Drug: SOC + Placebo

Primary Outcomes

Description: Mortality status

Measure: Mortality

Time: 30 days post hospitalization

Secondary Outcomes

Description: Percent change in PCR copy number from first measurement

Measure: Virologic response to study treatment detected in blood

Time: Day 30 relative to admission Day 0

Description: Presence or absence of SARS-CoV-2 Viral RNA in Nasopharyngeal swab or lower respiratory secretions

Measure: Virologic clearance in nasal swab and/or lower respiratory secretions

Time: Day 6 and Day 30

Description: Measured by 7-point ordinal scale: from (1) death, to (7) not hospitalized, no limit on daily activities

Measure: Clinical Severity

Time: Measured on study Days 3, 5, 8, 11, 15 and 30.

Description: Measured by National Early Warning Score (NEWS): vital sign based score from 0-20, higher score indicates higher degree of illness

Measure: Clinical Severity

Time: Measured on study Days 3, 5, 8, 11, 15 and 30.

Description: Measured by duration of use of supplemental oxygen (if applicable)

Measure: Clinical Severity

Time: Measured on study Days 3, 5, 8, 11, 15 and 30.

Description: Measured by duration of use of mechanical ventilation (if applicable)

Measure: Clinical Severity

Time: Measured on study Days 3, 5, 8, 11, 15 and 30.

Description: Measured by duration of hospitalization

Measure: Clinical Severity

Time: Measured on study Days 3, 5, 8, 11, 15 and 30.

Other Outcomes

Description: Incidence of new onset lymphopenia during hospitalization measured by blood draw

Measure: Incidence of New Onset Lymphopenia

Time: Through study completion, average of 30 days


No related HPO nodes (Using clinical trials)