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Withdrawn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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Administration of placebo daily during hospitalization
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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
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Drug: Rapamycin
Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized
Other Names:
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- Survival rate [ Time Frame: 4 weeks ]The proportion of participants who survive without respiratory failure
- 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
- 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)
- All cause mortality [ Time Frame: 4 weeks ]Total number of deaths during the study period
- Duration of ECMO [ Time Frame: Up to 4 weeks ]Number of days on ECMO
- Duration of supplemental oxygen [ Time Frame: Up to 4 weeks ]Number of days participants are on supplemental oxygen
- Length of hospital stay [ Time Frame: Up to 4 weeks ]Days of hospitalization
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Over 60 years of age clinically judged to require hospitalization
- SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab
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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

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
United States, Texas | |
University Hospital System | |
San Antonio, Texas, United States, 78228 | |
Audie L Murphy Memorial Veterans Hospital | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Dean L Kellogg, MD, PhD | University of Texas Health at San Antonio |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Acute Lung Injury Lung Injury Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections 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 |