Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

NCT04341675 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2020-0337
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.

  Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP\* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. \* CPAP use for known obstructive sleep apnea will not be considered as disease progression.

  28 days

Secondary Outcomes (4)

• Percentage of Patients Surviving to Hospital Discharge

  28 days

• Drug Safety Profile

  28 days

• Duration of Hospital Stay

  days

• Number of Patients Who Require Initiation of Off-label Therapies

  28 days

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.

Drug: Sirolimus

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Sirolimus DRUG

Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.

Also known as: Rapamycin

Sirolimus

Placebo DRUG

Matching placebo

Also known as: placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

Loyola University Medical Center

Chicago, Illinois, 60153, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Nishant Gupta, MD
• Organization: University of Cincinnati

Nishant.Gupta@uc.edu

513-558-4861

Study Officials

• Nishant Gupta, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Model Details: Randmized, double blind, placebo controlled

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 10, 2020
• Study Start: April 24, 2020
• Primary Completion: July 15, 2020
• Study Completion: September 15, 2020
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after the initial study publication.
• Access Criteria: Data use agreement between the University of Cincinnati and the requesting entity.

Locations

US (2)