Status:
TERMINATED
Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with a...
Detailed Description
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with a...
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
- Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
- 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
- A previous stem cell infusion unrelated to this trial
- Certain medical conditions that pose a safety risk to the subject
- Pregnant or breast feeding or planning to during the study
- Suspected uncontrolled active bacterial, fungal, viral, or other infection
- History of splenectomy, lung transplant, or lung lobectomy
- Concurrent participation in another clinical trial involving therapeutic interventions
- 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) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04903327
Start Date
November 16 2021
End Date
November 23 2022
Last Update
January 9 2023
Active Locations (6)
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1
Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, Brazil
2
Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
Salvador, Estado de Bahia, Brazil
3
Saraiva & Berlinger Ltda. - EPP (IPECC)
Campinas, São Paulo, Brazil
4
CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
Jaú, São Paulo, Brazil