Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Covid19, ARDS

In brief

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.

Key facts

Study ID

NCT04728698

Run by

Sorrento Therapeutics, Inc.

People needed

0

Starts

2021-03-01

Expected to finish

2021-09-01

Last updated by the study team

2021-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fresno Community Hospital — Fresno, California, United States

Full record on ClinicalTrials.gov

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