Status:
UNKNOWN
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
Lead Sponsor:
Stemedica Cell Technologies, Inc.
Collaborating Sponsors:
bioRASI, LLC
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04780685
Start Date
March 20 2021
End Date
December 31 2022
Last Update
July 8 2022
Active Locations (2)
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1
Providence Medical Foundation
Fullerton, California, United States, 92835
2
Providence Saint John's Health Center - Saint John's Cancer Institute
Santa Monica, California, United States, 90404