Friday, November 26, 2021 11:09:23 AM
PRIMARY COMPLETION in DECEMBER 2021
FINAL COMPLETION in FEBRUARY 2022
"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 Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022
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