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

S

Stemedica Cell Technologies

Status and phase

Enrolling
Phase 2

Conditions

Covid19

Treatments

Biological: hMSC

Study type

Interventional

Funder types

Industry

Identifiers

NCT04780685
STEM-107-COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:

  • 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.

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

hMSCs
Experimental group
Description:
hMSCs will be given via IV administration.
Treatment:
Biological: hMSC
Lactated Ringer's Solution
Placebo Comparator group
Description:
Lactated Ringer's Solution will be given via IV administration.
Treatment:
Biological: hMSC

Trial contacts and locations

2

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Central trial contact

Lev Verkh, PhD/MS

Data sourced from clinicaltrials.gov

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