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

MSC-COV-201BR

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.

2021-11-16

2022-08-29

2022-11-23

Terminated

Early phase I

43

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

2023-01-09