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.
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.
Drug: Rapamycin
Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized
Other Name: Array
Drug: Placebo
Administration of investigational drug placebo for up to 4 weeks while hospitalized
Other Name: Placebo Tablet or oral solution
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
University Hospital System
San Antonio, Texas, United States
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States
Dean L Kellogg, MD, PhD, Principal Investigator
University of Texas Health at San Antonio