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 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.

Detailed Description

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.

Unknown status
COVID19

Biological: COVI-MSC

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Drug: Placebo

Excipient solution

Eligibility Criteria

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

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

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

Contacts

Mike Royal, MD
(858) 203-4100 - 4146
mroyal@sorrentotherapeutics.com

Mike Royal, MD, Study Director
Sorrento Therapeutics, Inc.

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