Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorrento Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record)

• Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

• Requires oxygen supplementation at Screening

• Willing to follow contraception guidelines

Exclusion Criteria:

• Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving

• Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O

• A previous stem cell infusion unrelated to this trial

• 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

• Has an existing "Do Not Intubate" order

• Has undergone 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 (eg, obstructive sleep apnea)

• Has 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