Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04948203
Collaborator
(none)
60
1
3
10.7
5.6

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Hospitalized patients with a diagnosis of COVID-19 pneumonia will be referred to the study team for potential recruitment. Initial screening will take place using the existing medical record and in collaboration with the treating team. The study consists of 3 randomly assigned arms of varying dosages of the study drug

All procedures, with the exception of drug dosing and option sample analysis, align with the subject's standard of care. Prior to initiating study drug, the subject's standard of care labs, imaging and oxygen requirements will be reviewed.

Sirolimus will be administered as an oral medication. Subjects who are discharged prior to receiving 14 days of study drug will be provided with enough study drug to finish at home.

On-study evaluation includes measurement of vital signs and laboratory studies before and after a patient has received sirolimus while inpatient. As part of routine care, subjects will be seen daily while in the hospital and will be monitored through blood tests for general health as well as renal function. Vital signs will be monitored daily while in the hospital, physical exams, assessment of COVID-19, and CT scans or chest x-rays as necessary for routine care.

Subjects will return to clinic at 12 weeks for routine lab work and imaging as a part of study follow-up and will be assessed for pulmonary fibrosis at this time.

Additionally, University of Chicago Medicine patients will have the option to allow investigators to use leftovers from tubes of blood drawn for clinical tests that would otherwise be discarded. This will apply to any blood collected during that respective hospital stay as well as up to 1 year after study enrollment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
SECOVID: A Multi-center, Randomized, Dose-ranging Parallel-group Trial Assessing the Efficacy of Sirolimus in Hospitalized Patients With COVID-19 Pneumonia for the Prevention of Post-COVID Fibrosis
Actual Study Start Date :
Jul 9, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sirolimus 0.5mg

Subject will take Sirolimus 0.5mg orally daily for 14 days.

Drug: Sirolimus
Triangular-shaped tablet
Other Names:
  • RAPAMUNE
  • Active Comparator: Sirolimus 1mg

    Subject will take Sirolimus 1mg orally daily for 14 days.

    Drug: Sirolimus
    Triangular-shaped tablet
    Other Names:
  • RAPAMUNE
  • Active Comparator: Sirolimus 2mg

    Subject will take Sirolimus 2mg orally daily for 14 days.

    Drug: Sirolimus
    Triangular-shaped tablet
    Other Names:
  • RAPAMUNE
  • Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Pulmonary Fibrosis as evidenced by CT scan [12 Weeks]

      Number of patients with >10% pulmonary fibrosis on chest CT

    Secondary Outcome Measures

    1. 10% Threshold for Pulmonary Fibrosis evidenced by CT scan [12 Weeks]

      Number of patients with >10% pulmonary fibrosis on chest CT

    2. Qualitative Fibrotic markers on chest CT [12 Weeks]

      Number of patients with the presence or absence of chest CT imaging markers of fibrosis

    3. Quantitative Fibrosis Score on chest CT [12 Weeks]

      Quantitative Fibrosis Score on chest CT

    4. Duration of Increased Supplemental Oxygen from Baseline [84 Days]

      Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.

    5. Pulmonary Function Test impairment [12 Weeks]

      Number of subjects with the presence of abnormal indices of lung function tests

    Other Outcome Measures

    1. Safety - Rate of Liver Function Test abnormalities [12 Weeks]

      Number of patients in a study arm who develop severe impairment of liver function tests exceeding three times the upper limit of normal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults ≥ 18 years of age

    • Approval from the patient's primary inpatient service

    • Hospitalized

    • Diagnosed with COVID-19 pneumonia

    • Positive test for active SARS-CoV-2 infection

    • Requiring supplemental oxygen ≥ 5LNC or ≥ 40% FiO2.

    • Chest computed tomography (CT) at admission with < 10% pulmonary fibrosis

    • Ability to provide written informed consent on the part of the subject or, in the absence of decisional capacity of the subject, an appropriate surrogate (e.g. a legally authorized representative).

    Exclusion Criteria:
    • Known diagnosis of previous pulmonary fibrosis or an interstitial lung disease.

    • Clinical features or known diagnosis of malignancy or active non-COVID-19 infection, including untreated latent tuberculosis.

    • History of unstable or deteriorating cardiac disease (including myocardial infarction, coronary artery bypass surgery or angioplasty within the past 6 months, congestive heart failure requiring hospitalization within the past 6 months, or uncontrolled arrhythmia.

    • Known history of hypersensitivity to sirolimus.

    • History of unstable or deteriorating neurologic disease (including TIAs or stroke).

    • Pregnant or lactating females. Females of child bearing potential are required to have a negative pregnancy test prior to treatment and practice abstinence or prevent pregnancy by at least a barrier method of birth control.

    • Investigational therapy for any indication within 28 days prior to treatment.

    • Current treatment with any drugs that are strong inhibitors of CYP3A4.

    • Tofacitinib

    • Clarithromycin

    • Telithromycin

    • Nefazodone

    • Itraconazole

    • Ketoconazole

    • Atazanavir

    • Darunavir

    • Indinavir

    • Lopinavir

    • Nelfinavir

    • Ritonavir

    • Saquinavir

    • Tipranavir.

    • Inability or unwillingness to comply with the requirements for the trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    • Principal Investigator: Ayodeji Adegunsoye, MD, MS, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT04948203
    Other Study ID Numbers:
    • IRB21-0400
    First Posted:
    Jul 1, 2021
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of Chicago
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 26, 2021