Clinical trial NCT04482712: Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS
Official title: Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of Acute Respiratory Distress Syndrome (RAPA-CARDS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Respiratory Failure
Sars-CoV2
Keywords: COVID-19
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
First posted: 2020-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Clinical Status assessed by the World Health Organization (WHO) scale
timeFrame: Baseline to 4 weeks
measure: Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale
timeFrame: Baseline to 4 weeks
Other outcomes:
measure: All cause mortality
timeFrame: 4 weeks
measure: Duration of ECMO
timeFrame: Up to 4 weeks
measure: Duration of supplemental oxygen
timeFrame: Up to 4 weeks
measure: Length of hospital stay
timeFrame: Up to 4 weeks
measure: Length of time to SARS-CoV2 negativity
timeFrame: Up to 4 weeks
Locations:
city: San Antonio
country: United States
facility: University Hospital System
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Memorial Veterans Hospital
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Dean L Kellogg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: