Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress
- Conditions
- Covid19
- Interventions
- Biological: COVI-MSCDrug: Placebo
- Registration Number
- NCT04903327
- Lead Sponsor
- Sorrento Therapeutics, Inc.
- 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 acute respiratory distress syndrome.
- 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 acute respiratory distress syndrome.
COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.
Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COVI-MSC 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 Placebo Placebo Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
- Primary Outcome Measures
Name Time Method All-cause mortality rate at Day 28 Baseline through Day 28 All-cause mortality rate at Day 28
- Secondary Outcome Measures
Name Time Method All-cause mortality rate at Day 60 and Day 90 Baseline through Day 60 and Day 90 All-cause mortality rate at Day 60 and Day 90
Number of ventilator-free days through Day 28 Baseline through Day 28 Number of ventilator-free days through Day 28
Number of ICU days through Day 28 Baseline through Day 28 Number of ICU days through Day 28
Change in oxygenation Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28 Change in oxygenation as assessed using PaO2:FiO2 ratio
Change in clinical status Baseline to Day 28 Change in clinical status as assessed using the 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)
Trial Locations
- Locations (6)
Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
🇧🇷Salvador, BA, Brazil
Saraiva & Berlinger Ltda. - EPP (IPECC)
🇧🇷Campinas, SP, Brazil
Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
🇧🇷Salvador, BA, Brazil
CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
🇧🇷Jaú, SP, Brazil
Impar Serviços Hospitalares S/A (Hospital Nove de Julho)
🇧🇷São Paulo, SP, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
🇧🇷São Bernardo Do Campo, SP, Brazil