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

NCT ID: NCT04780685

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-20
• Study Completion Date: 2022-12-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hMSCs

hMSCs will be given via IV administration.

Group Type: EXPERIMENTAL

hMSC

Intervention Type: BIOLOGICAL

IV administration

Lactated Ringer's Solution

Lactated Ringer's Solution will be given via IV administration.

Group Type: PLACEBO_COMPARATOR

hMSC

Intervention Type: BIOLOGICAL

IV administration

Interventions

hMSC

IV administration

Intervention Type: BIOLOGICAL

Other Intervention Names

allogeneic mesenchymal bone marrow cells

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

bioRASI, LLC

INDUSTRY

Sponsor Role: collaborator

Stemedica Cell Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lev Verkh, PhD/MS

Role: STUDY_DIRECTOR

Stemedica Cell Technologies, Inc.

Santosh Kesari, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Saint John's Health Center - Saint John's Cancer

Locations

Providence Medical Foundation

Fullerton, California, United States

Site Status: RECRUITING

Providence Saint John's Health Center - Saint John's Cancer Institute

Santa Monica, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lev Verkh, PhD/MS

Role: CONTACT

lverkh@stemedica.com

8586580910

Facility Contacts

Linda Gozar, MPH

Role: primary

Linda.Gozar@stjoe.org

714-992-3000 ext. 4332

Hotline

Role: primary

neuro.research@providence.org

310-582-7448

Other Identifiers

STEM-107-COVID-19

Identifier Type: -

Identifier Source: org_study_id