This is a Phase II multi-center, double-blind, placebo-controlled, randomized study inPatients with moderate to severe lung injury due to COVID-19 or other potential viral andbacterial pathogens.
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.
Biological: hMSC
IV administration
Other Name: allogeneic mesenchymal bone marrow cells
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
Providence Medical Foundation
Fullerton, California, United States
Providence Saint John's Health Center - Saint John's Cancer Institute
Santa Monica, California, United States
Lev Verkh, PhD/MS
8586580910
lverkh@stemedica.com