Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress
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.
Purpose of Study
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.
Eligibility
Age:
18 +Sex:
AllKey Inclusion / Exclusion Criteria
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
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
Conditions:
COVID-19
Status:
Recruiting
Phase:
Phase 2
Study ID
NCT04903327
Read Detailed Summary
Start Date / End Date:
16/11/2021 -
Enrollment:
100
Full Details:
6 Study Locations
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
Saraiva & Berlinger Ltda. – EPP (IPECC)
Campinas, SP,
Brazil
CECIP JAU – Centro de Estudos Clínicos do Interior Paulista Ltda.
Jaú, SP,
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,
Brazil