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.
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of 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 stress (ARD) / acute respiratory distress syndrome (ARDS). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Teradan Clinical Trials LLC
Brandon, Florida, United States
RECRUITINGSarasota Memorial Health Care System (SMH)
Sarasota, Florida, United States
RECRUITINGSt Luke's Research
Boise, Idaho, United States
All-cause mortality rate at Day 28
All-cause mortality rate at Day 28
Time frame: Baseline through Day 28
Incidence of all adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Time frame: Baseline through study completion at Day 90
Incidence of treatment-emergent adverse events (safety)
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Time frame: Baseline through study completion at Day 90
Incidence of severe adverse events (safety)
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Time frame: Baseline through study completion at Day 90
Incidence of infusion-related adverse events (safety)
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
Time frame: Baseline to Hour 4
All-cause mortality rate at Day 60 and 90
All-cause mortality rate at Day 60 and 90
Time frame: Baseline through Day 60 and Day 90
Number of ventilator-free days through Day 28
Number of ventilator-free days through Day 28
Time frame: Baseline through Day 28
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St. Luke's Boise
Boise, Idaho, United States
RECRUITINGAscension St. John
Tulsa, Oklahoma, United States
RECRUITINGPRX Research/Dallas Regional Medical Center
Mesquite, Texas, United States
RECRUITINGNumber of ICU days through Day 28
Number of ICU days through day 28
Time frame: Baseline through Day 28
Change in clinical status
Change in clinical status as assessed using the WHO Clinical Progression Scale (0-10 scale, where lower score means a better outcome) at Day 28
Time frame: Baseline to Day 28
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio
Time frame: Baseline to Day 14 Day 28, and Day 60