NCT04903327

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	COVI-MSC	COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
DRUG	Placebo	Excipient solution

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-08-29
• Completion: 2022-11-23
• First posted: 2021-05-26
• Last updated: 2023-01-09

Locations

6 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study