Back to resultsA Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
Primary Purpose
Covid19
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hMSC
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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 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 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
Sites / Locations
- Providence Medical FoundationRecruiting
- Providence Saint John's Health Center - Saint John's Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hMSCs
Lactated Ringer's Solution
Arm Description
hMSCs will be given via IV administration.
Lactated Ringer's Solution will be given via IV administration.
Outcomes
Primary Outcome Measures
Survival
Number of patients alive at day 14 post treatment
Secondary Outcome Measures
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.
Full Information
NCT ID
NCT04780685
First Posted
March 1, 2021
Last Updated
July 7, 2022
Sponsor
Stemedica Cell Technologies, Inc.
Collaborators
bioRASI, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04780685
Brief Title
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemedica Cell Technologies, Inc.
Collaborators
bioRASI, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is double-blind study
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hMSCs
Arm Type
Experimental
Arm Description
hMSCs will be given via IV administration.
Arm Title
Lactated Ringer's Solution
Arm Type
Placebo Comparator
Arm Description
Lactated Ringer's Solution will be given via IV administration.
Intervention Type
Biological
Intervention Name(s)
hMSC
Other Intervention Name(s)
allogeneic mesenchymal bone marrow cells
Intervention Description
IV administration
Primary Outcome Measure Information:
Title
Survival
Description
Number of patients alive at day 14 post treatment
Time Frame
14 days post treatment
Secondary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Description
Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lev Verkh, PhD/MS
Phone
8586580910
Email
lverkh@stemedica.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lev Verkh, PhD/MS
Organizational Affiliation
Stemedica Cell Technologies, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Santosh Kesari, MD
Organizational Affiliation
Providence Saint John's Health Center - Saint John's Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Gozar, MPH
Phone
714-992-3000
Ext
4332
Email
Linda.Gozar@stjoe.org
First Name & Middle Initial & Last Name & Degree
David Park, MD
Facility Name
Providence Saint John's Health Center - Saint John's Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hotline
Phone
310-582-7448
Email
neuro.research@providence.org
First Name & Middle Initial & Last Name & Degree
Santosh Kesari, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
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