Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress
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 / acute respiratory distress syndrome.
Purpose of Study
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.
Eligibility
Age:
18 +Sex:
AllKey Inclusion / Exclusion 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
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
Conditions:
COVID-19
Status:
Recruiting
Phase:
Phase 2
Study ID
NCT04905836
Read Detailed Summary
Start Date / End Date:
16/11/2021 -
Enrollment:
60
Full Details:
6 Study Locations
United States
Teradan Clinical Trials LLC
Brandon, Florida, 33511
United States
email: STUDIES@TERADANCLINICALTRIALS.COM
phone: 813-603-4509
Sarasota Memorial Health Care System (SMH)
Sarasota, Florida, 34239
United States
phone: 941-917-2225
St. Luke’s Boise
Boise, Idaho, 83702
United States
phone: 208-381-7092
Ascension St. John
Tulsa, Oklahoma, 74104
United States
phone: 918-744-3426
PRX Research/Dallas Regional Medical Center
Mesquite, Texas, 75149
United States
phone: 214-320-7000
St Luke’s Research
Boise, Idaho, 83702
United States