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

NCT04482712 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HSC20200489H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Survival rate

  The proportion of participants who survive without respiratory failure

  4 weeks

Secondary Outcomes (2)

• Change in Clinical Status assessed by the World Health Organization (WHO) scale

  Baseline to 4 weeks

• Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale

  Baseline to 4 weeks

Other Outcomes (5)

• All cause mortality

  4 weeks

• Duration of ECMO

  Up to 4 weeks

• Duration of supplemental oxygen

  Up to 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Administration of placebo daily during hospitalization

Drug: Placebo

Rapamycin

ACTIVE COMPARATOR

Administration of rapamycin (sirolimus) 1mg daily during hospitalization

Drug: Rapamycin

Interventions

Rapamycin DRUG

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

Also known as: Sirolimus, Rapamune, RAPA

Rapamycin

Placebo DRUG

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

Also known as: Placebo Tablet or oral solution

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 60 years of age clinically judged to require hospitalization
• SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab
• 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
• Elevated ferritin
• Lymphopenia
• Bilateral opacities on chest x-ray
• Low pro-calcitonin
• 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.

You may not qualify if:

• Known or suspected allergy to RAPA
• High pro-calcitonin
• SARS-CoV2 documented by negative RT-PCR nasopharyngeal swab
• 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.
• Currently receiving immunosuppressants, including steroids, prior to enrollment
• 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
• Suspected or confirmed history of alcohol or substance abuse disorder
• Having participated in other drug trials in the past month
• Deemed otherwise unsuitable for the study by researchers
• Clinically judged to not require hospital admission

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Claude D. Pepper Older Americans Independence Centers: collaborator

Study Sites (2)

University Hospital System

San Antonio, Texas, 78228, United States

Location

Audie L Murphy Memorial Veterans Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Respiratory Insufficiency; COVID-19

Interventions

Sirolimus; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pharmaceutical Preparations

Study Officials

• Dean L Kellogg, MD, PhD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 22, 2020
• Study Start: April 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available at study completion at the time of journal publication.

Locations

US (2)