Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with 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

• Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300

• 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

• A previous stem cell infusion unrelated to this trial

• Certain medical conditions that pose a safety risk to the subject

• Pregnant or breast feeding or planning to during the study

• Suspected uncontrolled active bacterial, fungal, viral, or other infection

• History of splenectomy, lung transplant, or lung lobectomy

• Concurrent participation in another clinical trial involving therapeutic interventions

• 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) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing