A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Stemedica Cell Technologies, Inc.
Updated on 6 February 2023

Summary

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

Description

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.

Details
Condition Covid19
Treatment hMSC
Clinical Study IdentifierNCT04780685
SponsorStemedica Cell Technologies, Inc.
Last Modified on6 February 2023

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