Phase 2
Completed N=28
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
Source: ClinicalTrials.gov NCT04341675 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28. — 15; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28. |
15; 8 | — |
| SECONDARY Percentage of Patients Surviving to Hospital Discharge |
17; 9 | — |
| SECONDARY Drug Safety Profile |
9; 5 | — |
| SECONDARY Duration of Hospital Stay |
9.9; 12.9 | — |
| SECONDARY Number of Patients Who Require Initiation of Off-label Therapies |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04341675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.