Status:
WITHDRAWN
Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
The Claude D. Pepper Older Americans Independence Centers
Conditions:
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Respiratory Failure
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
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 distres...
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, wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04482712
Start Date
April 1 2021
End Date
January 1 2023
Last Update
June 1 2021
Active Locations (2)
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1
University Hospital System
San Antonio, Texas, United States, 78228
2
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229