Status:
WITHDRAWN
Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hospital...
Eligibility Criteria
Inclusion
- 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
- 3\. 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
Exclusion
- Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
- A previous MSC infusion unrelated to this trial
- 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
- Pregnant or breast feeding or planning for either during the study
- Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
- History of a splenectomy, lung transplant or lung lobectomy;
- Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable).
- Expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days.
- Do Not Intubate order;
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04728698
Start Date
March 1 2021
End Date
September 1 2021
Last Update
September 16 2021
Active Locations (1)
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1
Fresno Community Hospital
Fresno, California, United States, 93710