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

NCT04780685 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

hMSC

IV administration

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Stemedica Cell Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Lev Verkh, PhD/MS · Stemedica Cell Technologies, Inc.

  • Santosh Kesari, MD · Providence Saint John's Health Center - Saint John's Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2022-09-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780685 on ClinicalTrials.gov