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.
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
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
Fresno Community Hospital
Fresno, California, United States
Mike Royal, MD, Study Director
Sorrento Therapeutics