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A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04780685
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
bioRASI, LLC
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: hMSC Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is double-blind study
Primary Purpose: Treatment
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
Estimated Study Start Date : March 20, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: hMSCs
hMSCs will be given via IV administration.
Biological: hMSC
IV administration
Other Name: allogeneic mesenchymal bone marrow cells

Placebo Comparator: Lactated Ringer's Solution
Lactated Ringer's Solution will be given via IV administration.
Biological: hMSC
IV administration
Other Name: allogeneic mesenchymal bone marrow cells




Primary Outcome Measures :
  1. Survival [ Time Frame: 14 days post treatment ]
    Number of patients alive at day 14 post treatment


Secondary Outcome Measures :
  1. Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 9 months ]
    Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780685


Contacts
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Contact: Lev Verkh, PhD/MS 8586580910 lverkh@stemedica.com

Locations
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United States, California
Providence Saint John's Health Center - Saint John's Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Ashley Archer    310-582-7460    ArcherA@jwci.org   
Principal Investigator: Santosh Kesari, MD         
United States, Texas
PRX Research, Dallas Regional Medical Center Not yet recruiting
Mesquite, Texas, United States, 75149
Contact: Adeel Shibli, MD    972-777-4428    admin@prxresearch.com   
Principal Investigator: Adeel Shibli, MD         
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
bioRASI, LLC
Investigators
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Study Director: Lev Verkh, PhD/MS Stemedica Cell Technologies, Inc.
Principal Investigator: Santosh Kesari, MD Providence Saint John's Health Center - Saint John's Cancer
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Responsible Party: Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04780685    
Other Study ID Numbers: STEM-107-COVID-19
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No