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

Phase 2

• Conditions: Covid19
• Interventions: Biological: hMSC

• Registration Number: NCT04780685
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Study Start: 2021-03-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hMSCs	hMSC	hMSCs will be given via IV administration.
Lactated Ringer's Solution	hMSC	Lactated Ringer's Solution will be given via IV administration.

Primary Outcome Measures

Name	Time	Method
Survival	14 days post treatment	Number of patients alive at day 14 post treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0	9 months	Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.

Trial Locations

Locations (2)

Providence Medical Foundation; 🇺🇸 Fullerton, California, United States

Providence Saint John's Health Center - Saint John's Cancer Institute; 🇺🇸 Santa Monica, California, United States