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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948203
• Other study ID #: IRB21-0400
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 9, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: Ayodeji Adegunsoye, MD, MS
• Phone: 773-702-4844
• Email: deji[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Fibrosis
• Long COVID
• Pneumonia
• Pulmonary Fibrosis

Intervention

Drug:
• Sirolimus
Triangular-shaped tablet

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety - Rate of Liver Function Test abnormalities	Number of patients in a study arm who develop severe impairment of liver function tests exceeding three times the upper limit of normal	12 Weeks
Primary	Prevalence of Pulmonary Fibrosis as evidenced by CT scan	Number of patients with >10% pulmonary fibrosis on chest CT	12 Weeks
Secondary	10% Threshold for Pulmonary Fibrosis evidenced by CT scan	Number of patients with >10% pulmonary fibrosis on chest CT	12 Weeks
Secondary	Qualitative Fibrotic markers on chest CT	Number of patients with the presence or absence of chest CT imaging markers of fibrosis	12 Weeks
Secondary	Quantitative Fibrosis Score on chest CT	Quantitative Fibrosis Score on chest CT	12 Weeks
Secondary	Duration of Increased Supplemental Oxygen from Baseline	Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.	84 Days
Secondary	Pulmonary Function Test impairment	Number of subjects with the presence of abnormal indices of lung function tests	12 Weeks