Trial | NCT04482712  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    Rapamycin ...

  • Study Participants

    0
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.
Study Started
Apr 30
2021
Anticipated
Primary Completion
Jan 31
2022
Anticipated
Study Completion
Jan 31
2023
Anticipated
Last Update
Jun 01
2021

Drug Rapamycin

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

  • Other names: Sirolimus, Rapamune, RAPA

Drug Placebo

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

  • Other names: Placebo Tablet or oral solution

Placebo Placebo Comparator

Administration of placebo daily during hospitalization

Rapamycin Active Comparator

Administration of rapamycin (sirolimus) 1mg daily during hospitalization

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted