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

Sorrento Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Covid19

ARDS

Treatments

Drug: COVI-MSC

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04728698

MSC-COV-201

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
1. 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