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

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 1. Bilateral chest radiograph infiltrates. 2. PaO2:FiO2 ratio of less than 200. 3. 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is double-blind study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
hMSCs 		hMSCs will be given via IV administration.
  • Biological: hMSC
    IV administration
    Other names:
    • allogeneic mesenchymal bone marrow cells
Placebo Comparator
Lactated Ringer's Solution 		Lactated Ringer's Solution will be given via IV administration.
  • Biological: hMSC
    IV administration
    Other names:
    • allogeneic mesenchymal bone marrow cells

Recruiting Locations

Providence Medical Foundation
Fullerton, California 92835
Contact:
Linda Gozar, MPH
714-992-3000
Linda.Gozar@stjoe.org

Providence Saint John's Health Center - Saint John's Cancer Institute
Santa Monica, California 90404
Contact:
Hotline
310-582-7448
neuro.research@providence.org

More Details

NCT ID
NCT04780685
Status
Unknown status
Sponsor
Stemedica Cell Technologies, Inc.

Study Contact

Lev Verkh, PhD/MS
8586580910
lverkh@stemedica.com

Detailed 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.