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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Hospital São Rafael S.A. - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, Brazil
Santa Casa de Misericórdia da Bahia (Hospital Santa Izabel)
Salvador, Estado de Bahia, Brazil
Saraiva & Berlinger Ltda. - EPP (IPECC)
Campinas, São Paulo, Brazil
CECIP JAU - Centro de Estudos Clínicos do Interior Paulista Ltda.
Jaú, São Paulo, Brazil
All-cause mortality rate at Day 28
All-cause mortality rate at Day 28
Time frame: Baseline through Day 28
All-cause mortality rate at Day 60 and Day 90
All-cause mortality rate at Day 60 and Day 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
Number 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 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome)
Time frame: Baseline to Day 28
Change in oxygenation
Change in oxygenation as assessed using PaO2:FiO2 ratio
Time frame: Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CEMEC - Centro Multidisciplinar de Estudos Clínicos Ltda. - EPP
São Bernardo do Campo, São Paulo, Brazil
Impar Serviços Hospitalares S/A (Hospital Nove de Julho)
São Paulo, São Paulo, Brazil