Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

COVID-19 Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341675
• Other study ID #: 2020-0337
• Status: Completed
• Phase: Phase 2
• Start date: April 24, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: April 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. 28 subjects were 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects enrolled in the trial must meet all of the following criteria.

• Confirmed COVID-19 pneumonia
• Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
• Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin =500ug/l, b) LDH =250U/L, c) d-dimer =1ug/L, or d) lymphopenia as defined by absolute lymphocyte count <1,000/uL
• Age = 18 years
• Completed informed consent Exclusion Criteria: Subjects who meet ANY of the following criteria are not eligible for enrollment as study

participants:

• Known allergy or hypersensitivity to sirolimus
• Inability or refusal to provide informed consent
• Advanced respiratory support (high flow oxygen = 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
• Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
• Pregnant women
• Breast feeding
• On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
• Any clinically significant medical disease which in the opinion of the investigator

precludes the patient from enrolling in the trial, including (but not limited to):

• History of liver cirrhosis
• End stage renal disease or need for renal replacement therapy
• Decompensated heart failure
• Known active tuberculosis or history of incompletely treated tuberculosis
• Uncontrolled systemic bacterial or fungal infections
• Active viral infection other than COVID-19

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Sirolimus
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.
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.	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.	28 days
Secondary	Percentage of Patients Surviving to Hospital Discharge	Survival to hospital discharge	28 days
Secondary	Drug Safety Profile	Number of patients with adverse events	28 days
Secondary	Duration of Hospital Stay	Length of hospitalization is measured as the number of days in the hospital from the date of randomization until the date of discharge or death from any cause, whichever came first, assessed up to 28 days post discharge.	days
Secondary	Number of Patients Who Require Initiation of Off-label Therapies	Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians	28 days