Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS

NCT ID: NCT04482712

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-01-31

Brief Summary

This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.

Detailed Description

This is a single center, double-blind, placebo-controlled, randomized clinical trial in which each participant, after admission to hospital with a diagnosis of mild to moderate COVID-19 infection, will be administered either a dose of rapamycin or the placebo daily. Each subject will receive the assigned treatment until hospital discharge or death. Evaluations will be performed at the beginning of the clinical trial and then daily up to 4 weeks.

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Respiratory Failure; Sars-CoV2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Administration of placebo daily during hospitalization

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administration of investigational drug placebo for up to 4 weeks while hospitalized

Rapamycin

Administration of rapamycin (sirolimus) 1mg daily during hospitalization

Group Type: ACTIVE_COMPARATOR

Rapamycin

Intervention Type: DRUG

Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized

Interventions

Rapamycin

Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized

Intervention Type: DRUG

Placebo

Administration of investigational drug placebo for up to 4 weeks while hospitalized

Intervention Type: DRUG

Other Intervention Names

Sirolimus; Rapamune; RAPA; Placebo Tablet or oral solution

Eligibility Criteria

Inclusion Criteria

1. Over 60 years of age clinically judged to require hospitalization

2. SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab

3. Mild to Moderate clinical status defined as clinical symptoms with or without pneumonia on imaging, with or without fever who are judged to require hospital admission

1. Elevated ferritin

2. Lymphopenia

3. Bilateral opacities on chest x-ray

4. Low pro-calcitonin

5. Clinical signs suggestive of symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea or moderate illness with CoVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute.

Exclusion Criteria

1. Known or suspected allergy to RAPA

2. High pro-calcitonin

3. SARS-CoV2 documented by negative RT-PCR nasopharyngeal swab

4. Treatment with contraindicated concomitant medications: currently receiving immunosuppressants, including steroids, prior to enrollment, or with immunomodulators or immunosuppressant drugs, including but not limited to Inter leukin (IL)-6 inhibitors, Tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents and Janus kinase (JAK) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.

5. Currently receiving immunosuppressants, including steroids, prior to enrollment

6. Serious underlying disease including but not limited to cardiac, pulmonary, renal, hepatic (bilirubin >1.5x Upper normal limit (ULN) or Aspartate Aminotransferase (AST)>ULN but bilirubin ≤ ULN), endocrine (diabetes) or psychiatric disorders judged to be at risk in participating by the inpatient attending physician or team

7. Suspected or confirmed history of alcohol or substance abuse disorder

8. Having participated in other drug trials in the past month

9. Deemed otherwise unsuitable for the study by researchers

10. Clinically judged to not require hospital admission

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Claude D. Pepper Older Americans Independence Centers

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean L Kellogg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health at San Antonio

Locations

University Hospital System

San Antonio, Texas, United States

Audie L Murphy Memorial Veterans Hospital

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20200489H

Identifier Type: -

Identifier Source: org_study_id