ARDS, Covid19
Conditions
Keywords
covid-19, ARDS
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.
Interventions
DRUGCOVI-MSC
1 x 10\^6 MSCs/kg or 1.5 x 10\^6 MSCs/kg, depending on CRP level
DRUGPlacebo
Equivalent volume of placebo will be administered
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at Day 28 | Randomization through Day 28 | All-cause mortality at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ventilator-free days | Randomization through Day 28 | Number of ventilator-free days through Day 28 |
| Improvement in oxygenation | Randomization to Day 2, Day 4, Day 6, Day 14, Day 28 | Improvement in oxygenation at Day 2, 4, 6, 14, and 28 compared to Baseline, as assessed by PaO2/FiO2 |
| Mortality at Days 60 and 90 | Randomization through Day 60 and Day 90 | All-cause mortality at Days 60 and 90 |
| SOFA score at Day 28 | Randomization to Day 28 | SOFA score at Day 28 compared to Baseline |
Countries
United States
Outcome results
None listed