Status:
UNKNOWN
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study to assess 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 distress / ac...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04905836
Start Date
November 16 2021
End Date
March 1 2023
Last Update
April 11 2022
Active Locations (6)
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1
Teradan Clinical Trials LLC
Brandon, Florida, United States, 33511
2
Sarasota Memorial Health Care System (SMH)
Sarasota, Florida, United States, 34239
3
St Luke's Research
Boise, Idaho, United States, 83702
4
St. Luke's Boise
Boise, Idaho, United States, 83702