Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Phase 1/2RAPA-CARDSNCT04482712
Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS
A Phase 1/2 study testing Rapamycin in people with Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) and Respiratory Failure, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Respiratory Failure, Sars-CoV2
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2021to Jan 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospital System
San Antonio, Texas, 78228
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, 78229
About this study
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)
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.
Read the 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.
- Conditions
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Respiratory Failure, Sars-CoV2
- Being tested
- Rapamycin, Placebo
- Keywords
- COVID-19
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus, Rapamune, RAPA
Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized
PlaceboDrug
Also called Placebo Tablet or oral solution
Administration of investigational drug placebo for up to 4 weeks while hospitalized
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administration of placebo daily during hospitalization Receives: Drug: Placebo |
| Rapamycin | Active comparator | Administration of rapamycin (sirolimus) 1mg daily during hospitalization Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The proportion of participants who survive without respiratory failure
Measured: 4 weeks
Secondary outcomes (2)
Change in Clinical Status assessed by the World Health Organization (WHO) scale
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
Measured: Baseline to 4 weeks
Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale
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)
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study startApr 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: The study was never submitted to IRB or approved, due to feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers
- Responsible party
- Sponsor
- Investigators
- Dean L Kellogg, MD, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482712
- Sponsor's protocol ID
- HSC20200489H
- Acronym
- RAPA-CARDS
- Status last verified
- May 2021
- First submitted
- 21 Jul 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04482712
- Acronym / sponsor ID
- RAPA-CARDS / HSC20200489H
- Conditions
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Respiratory Failure, Sars-CoV2
- Keywords
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never submitted to IRB or approved, due to feasibility issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo daily during hospitalization |
| Rapamycin | Active comparator | Drug: RapamycinAdministration of rapamycin (sirolimus) 1mg daily during hospitalization |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinAlso: Sirolimus, Rapamune, RAPADaily administration of a dose of investigational drug for up to 4 weeks while hospitalized | Drug | Rapamycin |
| PlaceboAlso: Placebo Tablet or oral solutionAdministration of investigational drug placebo for up to 4 weeks while hospitalized | Drug | Placebo |
Primary outcome
Survival rate
Time frame: 4 weeks
The proportion of participants who survive without respiratory failure
2 secondary outcomes
Change in Clinical Status assessed by the World Health Organization (WHO) scale
Time frame: Baseline to 4 weeks
Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale
Time frame: Baseline to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean L Kellogg, MD, PhD principal investigator
University of Texas Health at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rapamycin in people with Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) and Respiratory Failure, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.