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MSCs in COVID-19 ARDS

Primary Purpose

Mesenchymal Stromal Cells, Remestemcel-L, Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Remestemcel-L
Placebo
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stromal Cells focused on measuring mesenchymal stem cells, SARS-CoV-2, cytokine storm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 18 years or older
  • Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test

  • Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)

    • Bilateral opacities must be present on a chest radiograph or computerized tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
    • Respiratory failure not fully explained by cardiac failure or fluid overload.
    • Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
  • Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
  • Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
  • High sensitivity C-Reactive Protein (hs-CRP) or CRP serum level >4.0 mg/dL
  • Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5
  • Creatinine clearance of ≥ 30 mL/minute OR a creatinine clearance of 20-29 mL/minute with urine output of ≥0.3 mLs/kg/hour over the last 8 hours or ≥500 mLs over the last 24 hours
  • The patient or his/her legally authorized representative (LAR) is able to provide informed consent

Exclusion Criteria

  • Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
  • Females who are pregnant or lactating
  • Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
  • Patients with BMI >55
  • Patients with untreated HIV infection
  • Patients with malignancy who are within 12 months of active treatment with any chemotherapy, radiation or immunotherapy.
  • Patients who have been intubated for more than 72 hours in total at the time of randomization
  • Creatinine clearance less than 20 mL/minute or receiving renal replacement therapy
  • LFTs (isolated ALT or AST) > 8x upper limit of normal or > 5x upper limit of normal in the setting of other liver function abnormalities (i.e., total bilirubin ≥ 2x upper limit of normal)
  • Known hypersensitivity to DMSO or to porcine or bovine proteins
  • History of prior respiratory disease with requirement for supplemental oxygen
  • Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment
  • Receiving an investigational cellular therapy agent

Sites / Locations

  • Dignity Health
  • University of Southern California
  • Stanford University
  • Emory University
  • Lutheran Hospital
  • Ochsner Clinic
  • Maine Medical Center
  • University of Maryland
  • Brigham and Women's Hospital
  • University of Michigan
  • Dartmouth-Hitchcock
  • New York University Langone Health
  • Mount Sinai Health
  • Northwell Health
  • Duke University Medical Center
  • WakeMed
  • Cleveland Clinic Foundation
  • University of Pennsylvania Health System
  • Houston Methodist Hospital
  • Baylor, Smith & White
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remestemcel-L Plus Standard of Care

Placebo Plus Standard of Care

Arm Description

Intravenous infusion of remestemcel-L 2x10^6 MSC/kg of body weight plus standard of care

Placebo (Plasma-Lyte) plus standard of care

Outcomes

Primary Outcome Measures

Number of all-cause mortality
Number of all-cause mortality within 30 days of randomization.

Secondary Outcome Measures

Number of days alive off mechanical ventilatory support
Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.
Number of adverse events
Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.
Number of participants alive at day 7
Number of participants alive at day 14
Number of participants alive at day 60
Number of participants alive at day 90
Number of participants alive at 12 Months
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 7
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 14
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 21
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 30
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Length of stay
Hospital length of stay
Readmissions
number of readmission
Length of Stay in Intensive Care Unit
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 7
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 14
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 21
Change in serum hs-CRP concentration
Changes from baseline in serum hs-CRP concentration at days 30
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 7 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 14 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 21 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 30 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 7 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 21 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 14 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 30 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 7 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 14 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 21 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 30 days
Pulmonary symptoms
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Pulmonary symptoms
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization

Full Information

First Posted
April 28, 2020
Last Updated
April 18, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Mesoblast, Inc., National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04371393
Brief Title
MSCs in COVID-19 ARDS
Official Title
Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Mesoblast, Inc., National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Detailed Description
This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities. Patients will be randomized in a 1:1 allocation to intravenous infusion of MSCs (remestemcel-L) plus standard of care versus placebo plus standard of care for the treatment of COVID-19 related ARDS: Group 1: 2x10^6 MSC/kg of body weight plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) Group 2: Placebo (Plasma-Lyte) plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) (control) MSCs and placebo will initially be administered intravenously in the dose defined above at randomization. The rate of infusion may be tailored to the patient's respiratory status and fluid status, but the duration of infusion should not exceed 60 minutes. Patients will be followed for 90 days post randomization, with assessment of pulmonary symptoms at 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stromal Cells, Remestemcel-L, Acute Respiratory Distress Syndrome, COVID
Keywords
mesenchymal stem cells, SARS-CoV-2, cytokine storm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
This is a randomized clinical trial, in which the patients and investigators are masked to treatment assignment.
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remestemcel-L Plus Standard of Care
Arm Type
Experimental
Arm Description
Intravenous infusion of remestemcel-L 2x10^6 MSC/kg of body weight plus standard of care
Arm Title
Placebo Plus Standard of Care
Arm Type
Placebo Comparator
Arm Description
Placebo (Plasma-Lyte) plus standard of care
Intervention Type
Biological
Intervention Name(s)
Remestemcel-L
Intervention Description
administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered twice during the first week, with second infusion at 4 days following the first injection (± 1 day)
Primary Outcome Measure Information:
Title
Number of all-cause mortality
Description
Number of all-cause mortality within 30 days of randomization.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of days alive off mechanical ventilatory support
Description
Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.
Time Frame
60 days
Title
Number of adverse events
Description
Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.
Time Frame
30 days
Title
Number of participants alive at day 7
Time Frame
7 days
Title
Number of participants alive at day 14
Time Frame
14 days
Title
Number of participants alive at day 60
Time Frame
60 days
Title
Number of participants alive at day 90
Time Frame
90 days
Title
Number of participants alive at 12 Months
Time Frame
12 Months
Title
Number of participants with resolution and/or improvement of ARDS
Description
The number and percent of patients with resolution and/or improvement of ARDS at day 7
Time Frame
7 days
Title
Number of participants with resolution and/or improvement of ARDS
Description
The number and percent of patients with resolution and/or improvement of ARDS at day 14
Time Frame
14 days
Title
Number of participants with resolution and/or improvement of ARDS
Description
The number and percent of patients with resolution and/or improvement of ARDS at day 21
Time Frame
21 days
Title
Number of participants with resolution and/or improvement of ARDS
Description
The number and percent of patients with resolution and/or improvement of ARDS at day 30
Time Frame
30 days
Title
Severity of ARDS
Description
severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Time Frame
baseline and 7 days
Title
Severity of ARDS
Description
severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Time Frame
baseline and 14 days
Title
Severity of ARDS
Description
severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Time Frame
baseline and 21 days
Title
Severity of ARDS
Description
severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Time Frame
baseline and 30 days
Title
Length of stay
Description
Hospital length of stay
Time Frame
12 months
Title
Readmissions
Description
number of readmission
Time Frame
12 months
Title
Length of Stay in Intensive Care Unit
Time Frame
12 months
Title
Clinical Improvement Scale
Description
Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Time Frame
7 days
Title
Clinical Improvement Scale
Description
Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.
Time Frame
14 days
Title
Clinical Improvement Scale
Description
Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Time Frame
21 days
Title
Clinical Improvement Scale
Description
Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Time Frame
30 days
Title
Change in plasma hs-CRP concentration
Description
Changes from baseline in plasma hs-CRP concentration at days 7
Time Frame
baseline and 7 days
Title
Change in plasma hs-CRP concentration
Description
Changes from baseline in plasma hs-CRP concentration at days 14
Time Frame
baseline and 14 days
Title
Change in plasma hs-CRP concentration
Description
Changes from baseline in plasma hs-CRP concentration at days 21
Time Frame
baseline and 21 days
Title
Change in serum hs-CRP concentration
Description
Changes from baseline in serum hs-CRP concentration at days 30
Time Frame
baseline and 30 days
Title
Change in IL-6 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 7 days
Time Frame
baseline and 7 days
Title
Change in IL-6 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 14 days
Time Frame
baseline and 14 days
Title
Change in IL-6 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 21 days
Time Frame
baseline and 21 days
Title
Change in IL-6 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 30 days
Time Frame
baseline and 30 days
Title
Change in IL-8 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 7 days
Time Frame
baseline and 7 days
Title
Change in IL-8 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 21 days
Time Frame
baseline and 21 days
Title
Change in IL-8 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 14 days
Time Frame
baseline and 14 days
Title
Change in IL-8 inflammatory marker level
Description
Changes from baseline in IL-6 inflammatory marker level at 30 days
Time Frame
baseline and 30 days
Title
Change in TNF-alpha inflammatory marker level
Description
Changes from baseline in TNF-alpha inflammatory marker level at 7 days
Time Frame
baseline and 7 days
Title
Change in TNF-alpha inflammatory marker level
Description
Changes from baseline in TNF-alpha inflammatory marker level at 14 days
Time Frame
baseline and 14 days
Title
Change in TNF-alpha inflammatory marker level
Description
Changes from baseline in TNF-alpha inflammatory marker level at 21 days
Time Frame
baseline and 21 days
Title
Change in TNF-alpha inflammatory marker level
Description
Changes from baseline in TNF-alpha inflammatory marker level at 30 days
Time Frame
baseline and 30 days
Title
Pulmonary symptoms
Description
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Time Frame
6 months
Title
Pulmonary symptoms
Description
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 18 years or older Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria) Bilateral opacities must be present on a chest radiograph or computerized tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules. Respiratory failure not fully explained by cardiac failure or fluid overload. Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS: Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O High sensitivity C-Reactive Protein (hs-CRP) or CRP serum level >4.0 mg/dL Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5 Creatinine clearance of ≥ 30 mL/minute OR a creatinine clearance of 20-29 mL/minute with urine output of ≥0.3 mLs/kg/hour over the last 8 hours or ≥500 mLs over the last 24 hours The patient or his/her legally authorized representative (LAR) is able to provide informed consent Exclusion Criteria Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV) Females who are pregnant or lactating Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia Patients with BMI >55 Patients with untreated HIV infection Patients with malignancy who are within 12 months of active treatment with any chemotherapy, radiation or immunotherapy. Patients who have been intubated for more than 72 hours in total at the time of randomization Creatinine clearance less than 20 mL/minute or receiving renal replacement therapy LFTs (isolated ALT or AST) > 8x upper limit of normal or > 5x upper limit of normal in the setting of other liver function abnormalities (i.e., total bilirubin ≥ 2x upper limit of normal) Known hypersensitivity to DMSO or to porcine or bovine proteins History of prior respiratory disease with requirement for supplemental oxygen Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment Receiving an investigational cellular therapy agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annetine C Gelijns, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Mack, MD
Organizational Affiliation
Baylor Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Smith, MD
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Dignity Health
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Lutheran Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Health
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
WakeMed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor, Smith & White
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
IPD Sharing Access Criteria
Anyone who wishes to access the data.

Learn more about this trial

MSCs in COVID-19 ARDS

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