|drug3486||SOC + IFX-1 Wiki||0.71|
|drug3487||SOC + Intravenous Famotidine Wiki||0.71|
|D045169||Severe Acute Respiratory Syndrome NIH||0.03|
|D018352||Coronavirus Infections NIH||0.03|
There are 2 clinical trials
Phase II & Phase III: This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)
Description: 28-day all-cause mortalityMeasure: Mortality Time: Day 28
Description: Frequency, severity, and relatedness to study drug of serious and non-serious TEAEsMeasure: Treatment Emergent Adverse Events Time: Day1 to Day 60
Description: Proportion of patients with an improvement in the 8-point ordinal scaleMeasure: Safety Parameters Time: Day 15, Day 28
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 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
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports