This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care inhospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acuterespiratory distress / acute respiratory distress syndrome.
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and
preliminary efficacy of COVI-MSC in the setting of current standard of care in
hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute
respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).
Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be
administered intravenously on Day 0, Day 2, and Day 4.
Biological: COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Drug: Placebo
Excipient solution
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 (can be documented
from inpatient medical record)
- Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA
Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or
Prevention
- 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
- Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg
with PEEP ≥ 5cm H2O
- A previous stem cell infusion unrelated to this trial
- 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
- Has an existing "Do Not Intubate" order
- Has undergone 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 (eg,
obstructive sleep apnea)
- Has 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
Teradan Clinical Trials LLC
Brandon, Florida, United States
Sarasota Memorial Health Care System (SMH)
Sarasota, Florida, United States
St Luke's Research
Boise, Idaho, United States
St. Luke's Boise
Boise, Idaho, United States
Ascension St. John
Tulsa, Oklahoma, United States
PRX Research/Dallas Regional Medical Center
Mesquite, Texas, United States
Mike Royal, MD
(858) 203-4100 - 4146
mroyal@sorrentotherapeutics.com
Mike Royal, MD, Study Director
Sorrento Therapeutics, Inc.