Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (SCOPE)
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|ClinicalTrials.gov Identifier: NCT04341675|
Recruitment Status : Unknown
Verified May 2020 by Nishant Gupta, MD, MS, University of Cincinnati.
Recruitment status was: Recruiting
First Posted : April 10, 2020
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Sirolimus Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randmized, double blind, placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: Sirolimus
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.
Other Name: Rapamycin
Placebo Comparator: Placebo
Other Name: placebo capsules
- Proportion of patients who are alive and free from advanced respiratory support measures at day 28. [ Time Frame: 28 days ]
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.
- Proportion of patients who require escalation in care [ Time Frame: 14 days ]Progression to a higher level of care, e.g. ICU
- Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count) [ Time Frame: 14 days ]Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)
- Proportion of patients surviving to hospital discharge [ Time Frame: days ]Survival to hospital discharge
- Drug safety profile [ Time Frame: 14 days ]Incidence and type of adverse events
- Duration of advanced respiratory support [ Time Frame: days ]Number of days spent on advanced respiratory support measures
- Duration of hospital stay [ Time Frame: days ]Length of hospitalization (in patients who survive to discharge)
- Time from treatment initiation to death [ Time Frame: days ]Number of days between study initiation and death (in the subset of patients who die during the hospitalization)
- Time to resolution of fever [ Time Frame: 14 days ]Time (in days) to resolution of fever
- Proportion of patients who require initiation of off-label therapies [ Time Frame: 14 days ]Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341675
|Contact: Nishant Gupta, MDfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Active, not recruiting|
|Chicago, Illinois, United States, 60153|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Davis Alexandria 513-558-2187 email@example.com|
|Principal Investigator: Nishant Gupta, MD|
|Principal Investigator:||Nishant Gupta, MD||University of Cincinnati|