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Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial — CIRCA-19 RCT  

Covid19 Clinical Trial

Official title:
Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

Clinical Trial Summary

This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS). Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Covid19
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
Clinical Trial Details
NCT number NCT04865107
Study type Interventional
Source Ottawa Hospital Research Institute
Contact Duncan J Stewart, MD
Phone 613-798-5555
Email djstewart@ohri.ca
Status Recruiting
Phase Phase 2
Start date April 27, 2021
Completion date April 2022
View Details
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