Clinical trial NCT04341675: Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
Official title: Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randmized, double blind, placebo controlled
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of Patients Surviving to Hospital Discharge
timeFrame: 28 days
measure: Drug Safety Profile
timeFrame: 28 days
measure: Duration of Hospital Stay
timeFrame: days
measure: Number of Patients Who Require Initiation of Off-label Therapies
timeFrame: 28 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Nishant Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: