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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:
All

Key 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:

https://clinicaltrials.gov/ct2/show/NCT04905836

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6 Study Locations

United States

St Luke’s Research
Boise, Idaho, 83702
United States


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


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


Study Locations Map: