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

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

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.

Inclusion Criteria:

• 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 Criteria:

• 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