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

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Respiratory Failure, Sars-CoV2

In brief

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.

Key facts

Study ID

NCT04482712

Run by

The University of Texas Health Science Center at San Antonio

People needed

0

Starts

2021-04-01

Expected to finish

2023-01-01

Last updated by the study team

2021-06-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University Hospital System — San Antonio, Texas, United States
• Audie L Murphy Memorial Veterans Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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