ARDS, HumanPhase 1RECOVERNCT04629105
Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)
A Phase 1 study testing Longeveron Mesenchymal Stem Cells (LMSCs) in people with ARDS, Human and Covid19, run by Longeveron Inc. at 3 sites in United States.
Trial summary
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Covid19
- What is being tested?
- Longeveron Mesenchymal Stem Cells (LMSCs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jul 2020to Jul 2025
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female or any race or ethnicity.
- At least 18 years of age.
- Provide written informed consent. For subjects who are incapable of providing informed consent, written informed consent can be provided on behalf of the subject by a legally authorized representative (LAR).
- Diagnosis of mild to severe ARDS per the Berlin Definition of ARDS. More specifically, the following 3 conditions must be present.
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP). A patient may be included if the PaO2/FiO2 ratio < 200 with < 8 cm H2O PEEP if there is a contraindication to increased PEEP (evidence of barotrauma).
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
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- No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
- Confirmed diagnosis of infection with coronavirus or influenza virus.
- Willing to perform all assessments required for the study.
- Must agree to the collection of all blood samples per protocol.
- Must agree to have samples stored and used for secondary research.
Who cannot join
- Patient receiving Extracorporeal Membrane Oxygenation (ECMO).
- History of malignancy within previous 2.5 years, except for curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervical carcinoma.
- Prior positive test for any of the following without demonstration of resolution.
- Hepatitis B virus (HBV) surface antigen (HBsAg). ii. Viremic hepatitis C virus (HCV). iii. Human immunodeficiency virus-1 or -2 (HIV1 or 2 HIV2). iv. Human T-cell leukemia virus-I or -II (HTLV-I or HTLV-II). v. Syphilis.
- Female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
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- Be an organ transplant recipient, other than for corneal, bone, skin, ligament, or tendon transplant.
- Actively listing (or expected listing) for transplant of any organ, other than for corneal, bone, skin, ligament, or tendon transplant.
- Continuous use of any medication at immunosuppressive dosing for greater than 14 consecutive days over the past 3 months.
- Currently participating in an investigational therapeutic or device trial, or have participated in an investigational therapeutic or device trial within the previous 30 days, or participate in any other clinical trial for the duration of the time that the subject actively participates in this trial. However, use of hydroxychloroquine, remdesivir, lopinavir/ritonavir and ivermectin are allowed as well as convalescent plasma.. Exceptions for other experimental interventions related to treating the patient's acute illness may be made with prior approval of Longeveron.
- Any serious comorbid illness or any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study, or that may compromise the validity of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Miami VA Healthcare System
Miami, Florida, 33125
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 1 Double-blinded, Randomized, Placebo-controlled Study for COVID-19 and Influenza Virus-Elicited Acute Respiratory Distress Syndrome (ARDS) Using Lomecel-B
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.
Read the detailed description
Double-blinded, randomized, placebo-controlled study with 2 cohorts.
Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 2: 10 subjects treated with up to 3 doses of Placebo.
Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 4: 10 subjects treated with up to 3 doses of Placebo.
Each subject will be intravenously infused with 100 million Lomecel-B (formerly LMSCs) or placebo on Day 0. If no treatment-related AEs are seen after the infusion, a second infusion will be given on Day 3. If no treatment-related AEs are seen after the second infusion, a third infusion will be given Day 6.
Follow-up visits will be conducted: daily until hospital discharge; at Week 4 after treatment (with LMSCs or placebo) for patients already discharged; and at Month 6 after treatment (with LMSCs or placebo).
- Conditions
- ARDS, Human, Covid19
- Being tested
- Longeveron Mesenchymal Stem Cells (LMSCs), Placebo
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longeveron Mesenchymal Stem Cells (LMSCs)Biological
Longeveron Mesenchymal Stem Cells (LMSCs)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs) | Active comparator | Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million LMSCs. Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs) |
| Cohort (SARS-CoV-2): Arm 2 (Placebo) | Placebo comparator | Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 2: 10 subjects treated with up to 3 doses of Placebo. Receives: Other: Placebo |
| Cohort 2 (Flu): Arm 3 (LMSCs) | Active comparator | Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million LMSCs. Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs) |
| Cohort 2 (Flu): Arm 4 (Placebo) | Placebo comparator | Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 4: 10 subjects treated with up to 3 doses of Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Serious Adverse Events
Incidence of treatment-emergent serious adverse events (TE-SAEs) within 4 weeks after treatment, defined as one or more of the following untoward medical occurrences happening within the first 4 weeks after treatment.
- Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). ii. Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). iii. Event resulting in persistent or significant disability/incapacity. iv. Event resulting in death. v. Event leading to other clinically significant untoward laboratory test result(s) or medical condition(s), as determined by the Investigator.
Measured: Within 4 weeks after treatment
Number of Participants with Abnormal Clinical Significant Laboratory Values in Hematology.
Number of Participants with Abnormal Clinical Significant Lab Values in the Hematology testing will be assessed at Baseline and 6 Months.
Measured: Baseline to 6 Months
Number of Participants with Changes in Echocardiography Overall Assessment
Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 months, this change in overall assessment will be the outcome in numbers of particants with a change.
Measured: Baseline to 6 Months
Number of Participants with Changes to overall assessment of Electrocardiogram
Number of Participants with changes to Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 Months
Measured: Baseline to 6 Months
Time to recovery of Sp02
Time to recovery of Sp02 to 90% or higher on room air (or the oxygen concentration the patient had before acute illness) after 10 minutes of spontaneous breathing.
Measured: Baseline to 6 Months
Number of Participants with Abnormal Clinical Significant Lab Values in the Blood Chemistry testing.
Number of Participants with Abnormal Clinical Significant Lab Values in Blood Chemistry testing will be assessed at Baseline and 6 Months.
Measured: Baseline to 6 months
Number of Participants with Abnormal Clinical Significant Lab Values in the Coagulation.
Number of Participants with Abnormal Clinical Significant Lab Values in the Coagulation testing will be assessed at Baseline and 6 Months.
Measured: Baseline to 6 months
Number of Participants with Abnormal Clinical Significant Lab Values in the Urinalysis
Number of Participants with Abnormal Clinical Significant Lab Values in the Hematology testing will be assessed at Baseline and 6 Months.
Measured: Baseline to 6 months
Secondary outcomes (3)
Immunity
Geometric mean titer
Measured: Baseline to 6 Months
Change in Imaging via X-ray
Change in overall assessment via Lung imaging via chest X-ray will be assessed and compared between baseline and 6 months
Measured: Baseline to 6 Months
Change in Imaging via Computerized Tomography
Change in overall assessment via Lung imaging via computerized tomography will be assessed and compared between baseline and 6 months
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start24 Jul 2020
- Primary completionJun 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, placebo-controlled study with 2 cohorts. Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million LMSCs. Arm 2: 10 subjects treated with up to 3 doses of Placebo. Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million LMSCs. Arm 4: 10 subjects treated with up to 3 doses of Placebo. Each subject will be intravenously infused with 100 million LMSCs or placebo on Day 0. If no treatment-related AEs are seen after the infusion, a second infusion will be given on Day 3. If no treatment-related AEs are seen after the second infusion, a third infusion will be given Day 6. Follow-up visits will be conducted: daily until hospital discharge; at Week 4 after treatment (with LMSCs or placebo) for patients already discharged; and at Month 6 after treatment (with LMSCs or placebo).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longeveron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629105
- Sponsor's protocol ID
- 00-006
- Acronym
- RECOVER
- Status last verified
- Feb 2024
- First submitted
- 29 Sep 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blinded, Randomized, Placebo-controlled Study for COVID-19 and Influenza Virus-Elicited Acute Respiratory Distress Syndrome (ARDS) Using Lomecel-B
- ClinicalTrials.gov ID
- NCT04629105
- Acronym / sponsor ID
- RECOVER / 00-006
- Conditions
- ARDS, Human, Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Longeveron Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 16 Nov 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.
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.
Detailed description
Double-blinded, randomized, placebo-controlled study with 2 cohorts.
Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 2: 10 subjects treated with up to 3 doses of Placebo.
Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million Lomecel-B Arm 4: 10 subjects treated with up to 3 doses of Placebo.
Each subject will be intravenously infused with 100 million Lomecel-B (formerly LMSCs) or placebo on Day 0. If no treatment-related AEs are seen after the infusion, a second infusion will be given on Day 3. If no treatment-related AEs are seen after the second infusion, a third infusion will be given Day 6.
Follow-up visits will be conducted: daily until hospital discharge; at Week 4 after treatment (with LMSCs or placebo) for patients already discharged; and at Month 6 after treatment (with LMSCs or placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Double-blinded, randomized, placebo-controlled study with 2 cohorts. Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million LMSCs. Arm 2: 10 subjects treated with up to 3 doses of Placebo. Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million LMSCs. Arm 4: 10 subjects treated with up to 3 doses of Placebo. Each subject will be intravenously infused with 100 million LMSCs or placebo on Day 0. If no treatment-related AEs are seen after the infusion, a second infusion will be given on Day 3. If no treatment-related AEs are seen after the second infusion, a third infusion will be given Day 6. Follow-up visits will be conducted: daily until hospital discharge; at Week 4 after treatment (with LMSCs or placebo) for patients already discharged; and at Month 6 after treatment (with LMSCs or placebo).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs) | Active comparator | Biological: Longeveron Mesenchymal Stem Cells (LMSCs)Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million LMSCs. |
| Cohort (SARS-CoV-2): Arm 2 (Placebo) | Placebo comparator | Other: PlaceboCohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 2: 10 subjects treated with up to 3 doses of Placebo. |
| Cohort 2 (Flu): Arm 3 (LMSCs) | Active comparator | Biological: Longeveron Mesenchymal Stem Cells (LMSCs)Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million LMSCs. |
| Cohort 2 (Flu): Arm 4 (Placebo) | Placebo comparator | Other: PlaceboCohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 4: 10 subjects treated with up to 3 doses of Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female or any race or ethnicity.
- At least 18 years of age.
- Provide written informed consent. For subjects who are incapable of providing informed consent, written informed consent can be provided on behalf of the subject by a legally authorized representative (LAR).
- Diagnosis of mild to severe ARDS per the Berlin Definition of ARDS. More specifically, the following 3 conditions must be present.
- Confirmed diagnosis of infection with coronavirus or influenza virus.
Key exclusion criteria (11 listed)
- Patient receiving Extracorporeal Membrane Oxygenation (ECMO).
- History of malignancy within previous 2.5 years, except for curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervical carcinoma.
- Prior positive test for any of the following without demonstration of resolution.
- Female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
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 |
|---|---|---|
| Longeveron Mesenchymal Stem Cells (LMSCs)Longeveron Mesenchymal Stem Cells (LMSCs) | Biological | Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs), Cohort 2 (Flu): Arm 3 (LMSCs) |
| PlaceboPlacebo | Other | Cohort (SARS-CoV-2): Arm 2 (Placebo), Cohort 2 (Flu): Arm 4 (Placebo) |
Primary outcome
Incidence of Treatment-Emergent Serious Adverse Events
Time frame: Within 4 weeks after treatment
Incidence of treatment-emergent serious adverse events (TE-SAEs) within 4 weeks after treatment, defined as one or more of the following untoward medical occurrences happening within the first 4 weeks after treatment. i. Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). ii. Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). iii. Event resulting in persistent or significant disability/incapacity. iv. Event resulting in death. v. Event leading to other clinically significant untoward laboratory test result(s) or medical condition(s), as determined by the Investigator.
Number of Participants with Abnormal Clinical Significant Laboratory Values in Hematology.
Time frame: Baseline to 6 Months
Number of Participants with Abnormal Clinical Significant Lab Values in the Hematology testing will be assessed at Baseline and 6 Months.
Number of Participants with Changes in Echocardiography Overall Assessment
Time frame: Baseline to 6 Months
Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 months, this change in overall assessment will be the outcome in numbers of particants with a change.
Number of Participants with Changes to overall assessment of Electrocardiogram
Time frame: Baseline to 6 Months
Number of Participants with changes to Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 Months
Time to recovery of Sp02
Time frame: Baseline to 6 Months
Time to recovery of Sp02 to 90% or higher on room air (or the oxygen concentration the patient had before acute illness) after 10 minutes of spontaneous breathing.
Number of Participants with Abnormal Clinical Significant Lab Values in the Blood Chemistry testing.
Time frame: Baseline to 6 months
Number of Participants with Abnormal Clinical Significant Lab Values in Blood Chemistry testing will be assessed at Baseline and 6 Months.
Number of Participants with Abnormal Clinical Significant Lab Values in the Coagulation.
Time frame: Baseline to 6 months
Number of Participants with Abnormal Clinical Significant Lab Values in the Coagulation testing will be assessed at Baseline and 6 Months.
Number of Participants with Abnormal Clinical Significant Lab Values in the Urinalysis
Time frame: Baseline to 6 months
Number of Participants with Abnormal Clinical Significant Lab Values in the Hematology testing will be assessed at Baseline and 6 Months.
3 secondary outcomes
Immunity
Time frame: Baseline to 6 Months
Change in Imaging via X-ray
Time frame: Baseline to 6 Months
Change in Imaging via Computerized Tomography
Time frame: Baseline to 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Longeveron Mesenchymal Stem Cells (LMSCs) in people with ARDS, Human and Covid19, run by Longeveron Inc. at 3 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of Treatment-Emergent Serious Adverse Events (time frame: Within 4 weeks after treatment). The study lists 8 primary outcomes in all. 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 20 Feb 2024.