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

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.

Withdrawn
COVID19
ARDS

Drug: COVI-MSC

1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level

Drug: Placebo

Equivalent volume of placebo will be administered

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Fresno Community Hospital
Fresno, California, United States

Mike Royal, MD, Study Director
Sorrento Therapeutics

Sorrento Therapeutics, Inc.
NCT Number
Keywords
Covid-19
ARDS
MeSH Terms
COVID-19