CovidResearchTrials by Shray Alag


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SirolimusWiki

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


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.04
D007239 Infection NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials


1 Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)

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.

NCT04341675 COVID-19 Drug: Sirolimus Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: Progression to a higher level of care, e.g. ICU

Measure: Proportion of patients who require escalation in care

Time: 14 days

Description: 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 days

Description: Survival to hospital discharge

Measure: Proportion of patients surviving to hospital discharge

Time: days

Description: Incidence and type of adverse events

Measure: Drug safety profile

Time: 14 days

Description: Number of days spent on advanced respiratory support measures

Measure: Duration of advanced respiratory support

Time: days

Description: Length of hospitalization (in patients who survive to discharge)

Measure: Duration of hospital stay

Time: days

Description: 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: days

Description: Time (in days) to resolution of fever

Measure: Time to resolution of fever

Time: 14 days

Description: 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 days

2 Efficacy and Safety of Sirolimus for Treating COVID-19 Infection

This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection

NCT04461340 COVID 19 Drug: Sirolimus
MeSH:Infection

Primary Outcomes

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 days

Description: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart

Measure: Viral clearance

Time: 14 days

Secondary Outcomes

Description: Evaluate the lung extension of pneumonia at day 14

Measure: radiological lung extension

Time: 14 days

Description: incidence and type of adverse events

Measure: drug adverse events

Time: 28 days

Description: number of deaths to total number of patients

Measure: 28 day mortality

Time: 28 day

Description: deteriorated patients who need admission to intensive care unit

Measure: intensive care unit (ICU) admission rate

Time: 28 days

Description: duration from hospitalization to discharge

Measure: Duration of hospital stay

Time: 28 days


Related HPO nodes (Using clinical trials)