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

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ClinicalTrials.gov Identifier: NCT04482712
Recruitment Status : Withdrawn (The study was never submitted to IRB or approved, due to feasibility issues)
First Posted : July 22, 2020
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
The Claude D. Pepper Older Americans Independence Centers
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Respiratory Failure Sars-CoV2 Drug: Rapamycin Drug: Placebo Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind clinical trial
Primary Purpose: Treatment
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)
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Administration of placebo daily during hospitalization
 Drug: Placebo
Administration of investigational drug placebo for up to 4 weeks while hospitalized
Other Name: Placebo Tablet or oral solution
Active Comparator: Rapamycin
Administration of rapamycin (sirolimus) 1mg daily during hospitalization
 Drug: Rapamycin
Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized
Other Names:
  • Sirolimus
  • Rapamune
  • RAPA


Outcome Measures
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Primary Outcome Measures :
  1. Survival rate [ Time Frame: 4 weeks ]
    The proportion of participants who survive without respiratory failure


Secondary Outcome Measures :
  1. Change in Clinical Status assessed by the World Health Organization (WHO) scale [ Time Frame: Baseline to 4 weeks ]

    The WHO ordinal scale is a measure of clinical improvement using a scale score of 0-8, where 0 indicates a better outcome and 8 indicates death:

    Uninfected, no clinical oor virological evidence of infection 0 Ambulatory, no limitation of activities 1 Ambulatory, limitation of activities 2 Hospitalized Mild disease, no oxygen therapy 3 Hospitalized mild disease, oxygen by mask or nasal prongs 4 Hospitalized Severe Disease, non-invasive ventilation 5 Hospitalized severe disease, intubation and mechanical ventilation 6 Hospitalized severe disease, ventilation+organ support 7 Death 8


  2. Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale [ Time Frame: Baseline to 4 weeks ]

    An ordinal scale for clinical improvement scored from 1 to 8, where 1 represents death and 8 represents recovery to discharge from hospital with no limitation on activities:

    Death (1) Hospitalized, on invasive mechanical ventilation of extracorporeal membrane oxygenation (ECMO) (2) Hospitalized, on non-invasive ventilation or high flow oxygen devices (3) Hospitalized, requiring supplemental oxygen (4) Hospitalized, not requiring supplemental oxygen or ongoing medical care (6) Not hospitalized, limitation on activities &/or requiring supplemental home oxygen (7)

    Not hospitalized, no limitation on activities (8)



Other Outcome Measures:
  1. All cause mortality [ Time Frame: 4 weeks ]
    Total number of deaths during the study period

  2. Duration of ECMO [ Time Frame: Up to 4 weeks ]
    Number of days on ECMO

  3. Duration of supplemental oxygen [ Time Frame: Up to 4 weeks ]
    Number of days participants are on supplemental oxygen

  4. Length of hospital stay [ Time Frame: Up to 4 weeks ]
    Days of hospitalization

  5. Length of time to SARS-CoV2 negativity [ Time Frame: Up to 4 weeks ]
    Number of days until there is a negative response to the reverse transcriptase-polymerase chain reaction test (RT-PCR)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482712


Locations
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United States, Texas
University Hospital System
San Antonio, Texas, United States, 78228
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
The Claude D. Pepper Older Americans Independence Centers
Investigators
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Principal Investigator: Dean L Kellogg, MD, PhD University of Texas Health at San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04482712    
Other Study ID Numbers: HSC20200489H
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available at study completion at the time of journal publication.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
COVID-19
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs