Clinical trial NCT04780685: A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Stemedica Cell Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: bioRASI, LLC
First posted: 2021-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival
timeFrame: 14 days post treatment
Secondary outcomes:
measure: Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 9 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center - Saint John's Cancer Institute
state: California
Study officials:
affiliation: Stemedica Cell Technologies, Inc.
name: Lev Verkh, PhD/MS
role: STUDY_DIRECTOR
affiliation: Providence Saint John's Health Center - Saint John's Cancer
name: Santosh Kesari, MD
role: PRINCIPAL_INVESTIGATOR
References: