Covid19 Clinical Trial
Official title:
Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Verified date | January 2023 |
Source | Sorrento Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 acute respiratory distress syndrome.
Status | Terminated |
Enrollment | 43 |
Est. completion date | November 23, 2022 |
Est. primary completion date | August 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Saraiva & Berlinger Ltda. - EPP (IPECC) | Campinas | SP |
Brazil | CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda. | Jaú | SP |
Brazil | Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino | Salvador | BA |
Brazil | Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel) | Salvador | BA |
Brazil | CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP | São Bernardo Do Campo | SP |
Brazil | Impar Serviços Hospitalares S/A (Hospital Nove de Julho) | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Sorrento Therapeutics, Inc. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality rate at Day 28 | All-cause mortality rate at Day 28 | Baseline through Day 28 | |
Secondary | All-cause mortality rate at Day 60 and Day 90 | All-cause mortality rate at Day 60 and Day 90 | Baseline through Day 60 and Day 90 | |
Secondary | Number of ventilator-free days through Day 28 | Number of ventilator-free days through Day 28 | Baseline through Day 28 | |
Secondary | Number of ICU days through Day 28 | Number of ICU days through Day 28 | Baseline through Day 28 | |
Secondary | Change in clinical status | Change in clinical status as assessed using the 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome) | Baseline to Day 28 | |
Secondary | Change in oxygenation | Change in oxygenation as assessed using PaO2:FiO2 ratio | Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28 |
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