|drug471||HCQ + Intravenous Famotidine Wiki||1.00|
|drug865||Placebo oral tablet Wiki||0.20|
|D003141||Communicable Diseases NIH||0.11|
|D045169||Severe Acute Respiratory Syndrome NIH||0.06|
|D018352||Coronavirus Infections NIH||0.05|
There is one clinical trial.
The overall objective of the study will be to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral management using hydroxychloroquine, or SOC with hydroxychloroquine combined with high-dose intravenous famotidine, in hospitalized patients meeting nucleic acid diagnostic and radiologic criteria for COVID-19 disease. The trial will statistically compare the clinical benefit afforded by the two treatment strategies to internal historical "standard of care" data from Northwell patents treated without benefit of either hydroxychloroquine or high-dose famotidine. We will compare clinical outcomes associated with hydroxychloroquine and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 600 COVID-19 patients hospitalized with moderate to severe disease into each of the two active treatment arms, with a total enrollment target of at least 1200 patients. The proposed trial has been designed for rapid enrollment and completion and powered to support two 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.
Description: Mortality statusMeasure: Mortality Time: 30 days post hospitalization
Description: Percent change in PCR copy number from first measurementMeasure: 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 secretionsMeasure: 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 activitiesMeasure: 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 illnessMeasure: 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 hospitalizationMeasure: Clinical Severity Time: Measured on study Days 3, 5, 8, 11, 15 and 30.
Description: Incidence of new onset lymphopenia during hospitalization measured by blood drawMeasure: Incidence of New Onset Lymphopenia Time: Through study completion, average of 30 days