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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    40
  • sponsor
    Stemedica Cell Technologies, Inc.
Updated on 9 August 2021

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 on9 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition
Bilateral chest radiograph infiltrates
PaO2:FiO2 ratio of less than 200
Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
Absence of moribund state that would indicate imminent demise and poor chance of survival

Exclusion Criteria

Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded
Breastfeeding mothers
Patients on ECMO
Receiving concurrent treatment with an investigational agent in a clinical trial
Exception: Use of COVID-19 convalescent plasma is permitted
More than 72hrs on mechanical ventilation before randomization
Receiving concurrent investigational vaccine
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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