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

NCT04780685 | Unknown Phase 2 FDA Drug

• 1 other identifier: STEM-107-COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Survival

  Number of patients alive at day 14 post treatment

  14 days post treatment

Secondary Outcomes (1)

• Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

  9 months

Study Arms (2)

hMSCs

EXPERIMENTAL

hMSCs will be given via IV administration.

Biological: hMSC

Lactated Ringer's Solution

PLACEBO COMPARATOR

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

Biological: hMSC

Interventions

hMSC BIOLOGICAL

IV administration

Also known as: allogeneic mesenchymal bone marrow cells

Lactated Ringer's Solution; hMSCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stemedica Cell Technologies, Inc.: lead
• bioRASI, LLC: collaborator

Study Sites (2)

Providence Medical Foundation

Fullerton, California, 92835, United States

RECRUITING

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

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lev Verkh, PhD/MS

  Stemedica Cell Technologies, Inc.

  STUDY DIRECTOR

• Santosh Kesari, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lev Verkh, PhD/MS

CONTACT

8586580910; lverkh@stemedica.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: March 20, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)