Status:
COMPLETED
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
Lead Sponsor:
University of Cincinnati
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 bli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04341675
Start Date
April 24 2020
End Date
September 15 2020
Last Update
April 5 2024
Active Locations (2)
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1
Loyola University Medical Center
Chicago, Illinois, United States, 60153
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267