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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental hMSCs |
hMSCs will be given via IV administration. |
|
|
Placebo Comparator Lactated Ringer's Solution |
Lactated Ringer's Solution will be given via IV administration. |
|
Recruiting Locations
Fullerton, California 92835
Santa Monica, California 90404
More Details
- NCT ID
- NCT04780685
- Status
- Unknown status
- Sponsor
- Stemedica Cell Technologies, Inc.
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.