Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04905836

Run by

Sorrento Therapeutics, Inc.

People needed

60

Starts

2021-11-16

Expected to finish

2023-03-01

Last updated by the study team

2022-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Teradan Clinical Trials LLC — Brandon, Florida, United States (enrolling)
• Sarasota Memorial Health Care System (SMH) — Sarasota, Florida, United States (enrolling)
• St Luke's Research — Boise, Idaho, United States (enrolling)
• St. Luke's Boise — Boise, Idaho, United States (enrolling)
• Ascension St. John — Tulsa, Oklahoma, United States (enrolling)
• PRX Research/Dallas Regional Medical Center — Mesquite, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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