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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2; Phase 1

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

Treatments: Drug: Placebo; Drug: Rapamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04482712

HSC20200489H

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Administration of placebo daily during hospitalization

Treatment:

Drug: Placebo

Rapamycin

Active Comparator group

Description:

Administration of rapamycin (sirolimus) 1mg daily during hospitalization

Treatment:

Drug: Rapamycin