Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress
- Registration Number
- NCT04728698
- Lead Sponsor
- Sorrento Therapeutics, Inc.
- Brief Summary
This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Provides informed consent
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
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- Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤300. The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
- Requires oxygen supplementation at screening
- Is willing to follow contraception requirements
-
Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
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A previous MSC infusion unrelated to this trial
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Have any of the following medical conditions:
- Cardio-pulmonary resuscitation within 14 days of randomization
- Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll
- Myocardial infarction within the last 6 weeks
- Congestive heart failure (NYHA Grade 3 or 4)
- Pulmonary hypertension (WHO Class III/IV)
- Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)
- Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN)
- Relevant renal impairment (eGFR < 50 mL/min)
- Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
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Pregnant or breast feeding or planning for either during the study
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Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
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History of a splenectomy, lung transplant or lung lobectomy;
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Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable).
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Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days.
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Do Not Intubate order;
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Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COVI-MSC COVI-MSC Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) Placebo Placebo Excipient
- Primary Outcome Measures
Name Time Method Mortality at Day 28 Randomization through Day 28 All-cause mortality at Day 28
- Secondary Outcome Measures
Name Time Method Improvement in oxygenation Randomization to Day 2, Day 4, Day 6, Day 14, Day 28 Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2
Mortality at Days 60 and 90 Randomization through Day 60 and Day 90 All-cause mortality at Days 60 and 90
SOFA score at Day 28 Randomization to Day 28 SOFA score at Day 28 compared to Baseline
Number of ventilator-free days Randomization through Day 28 Number of ventilator-free days through Day 28
Trial Locations
- Locations (1)
Fresno Community Hospital
🇺🇸Fresno, California, United States