Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress
NCT ID: NCT04905836
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2021-11-16
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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COVI-MSC
Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Placebo
Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
Placebo
Excipient solution
Interventions
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COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Placebo
Excipient solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sorrento Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mike Royal, MD
Role: STUDY_DIRECTOR
Sorrento Therapeutics, Inc.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kirk Voelker, MD
Role: primary
Lejla Godusevic
Role: primary
Karen Miller, MD
Role: primary
Stacie Merritt, MSN, RN-BC
Role: primary
Muhammad Saeed, MD
Role: primary
Other Identifiers
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MSC-COV-202
Identifier Type: -
Identifier Source: org_study_id
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