A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Stemedica Cell Technologies, Inc.
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Survival
- Last Updated
- 3 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Survival
Time Frame: 14 days post treatment
Number of patients alive at day 14 post treatment
Secondary Outcomes
- Number of patients with treatment-related adverse events as assessed by CTCAE v4.0(9 months)