Status:
TERMINATED
MSCs in COVID-19 ARDS
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Mesoblast, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Mesenchymal Stromal Cells
Remestemcel-L
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 des...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2022
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT04371393
Start Date
April 30 2020
End Date
January 2 2022
Last Update
April 25 2022
Active Locations (21)
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1
Dignity Health
Gilbert, Arizona, United States, 85297
2
University of Southern California
Los Angeles, California, United States, 90033
3
Stanford University
Stanford, California, United States, 94305
4
Emory University
Atlanta, Georgia, United States, 30308