Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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There are 2 clinical trials
The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 30 subjects will be randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.
Description: Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. * CPAP use for known obstructive sleep apnea will not be considered as disease progression.
Measure: Proportion of patients who are alive and free from advanced respiratory support measures at day 28. Time: 28 daysDescription: Progression to a higher level of care, e.g. ICU
Measure: Proportion of patients who require escalation in care Time: 14 daysDescription: Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)
Measure: Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count) Time: 14 daysDescription: Survival to hospital discharge
Measure: Proportion of patients surviving to hospital discharge Time: daysDescription: Incidence and type of adverse events
Measure: Drug safety profile Time: 14 daysDescription: Number of days spent on advanced respiratory support measures
Measure: Duration of advanced respiratory support Time: daysDescription: Length of hospitalization (in patients who survive to discharge)
Measure: Duration of hospital stay Time: daysDescription: Number of days between study initiation and death (in the subset of patients who die during the hospitalization)
Measure: Time from treatment initiation to death Time: daysDescription: Time (in days) to resolution of fever
Measure: Time to resolution of fever Time: 14 daysDescription: Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians
Measure: Proportion of patients who require initiation of off-label therapies Time: 14 daysThis research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection
Description: The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.
Measure: Time to clinical recovery Time: 14-28 daysDescription: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Measure: Viral clearance Time: 14 daysDescription: Evaluate the lung extension of pneumonia at day 14
Measure: radiological lung extension Time: 14 daysDescription: incidence and type of adverse events
Measure: drug adverse events Time: 28 daysDescription: number of deaths to total number of patients
Measure: 28 day mortality Time: 28 dayDescription: deteriorated patients who need admission to intensive care unit
Measure: intensive care unit (ICU) admission rate Time: 28 daysDescription: duration from hospitalization to discharge
Measure: Duration of hospital stay Time: 28 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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