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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04780685
• Other study ID #: STEM-107-COVID-19
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Stemedica Cell Technologies, Inc.
• Contact: Lev Verkh, PhD/MS
• Phone: 8586580910
• Email: lverkh[@]stemedica.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• hMSC
IV administration

Locations

Country	Name	City	State
United States	Providence Medical Foundation	Fullerton	California
United States	Providence Saint John's Health Center - Saint John's Cancer Institute	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Stemedica Cell Technologies, Inc.	bioRASI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Number of patients alive at day 14 post treatment	14 days post treatment
Secondary	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.	9 months