Name (Synonyms) | Correlation | |
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drug2165 | SOC + Placebo Wiki | 1.00 |
drug1150 | IMU-838 Wiki | 1.00 |
drug1822 | Placebo Wiki | 0.06 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
Description: Mortality status
Measure: Mortality Time: 30 days post hospitalizationDescription: 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 0Description: 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 30Description: 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.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