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MSCs in COVID-19 ARDS

NCT04371393 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2022-04-25

No results posted yet for this study

Summary

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS.

The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

Conditions

  • Mesenchymal Stromal Cells
  • Remestemcel-L
  • Acute Respiratory Distress Syndrome
  • COVID

Interventions

BIOLOGICAL

Remestemcel-L

administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day)

DRUG

Placebo

administered twice during the first week, with second infusion at 4 days following the first injection (± 1 day)

Sponsors & Collaborators

Principal Investigators

  • Annetine C Gelijns, PhD · Icahn School of Medicine at Mount Sinai

  • Michael Mack, MD · Baylor Research Institute

  • Peter Smith, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-01-14
Completion
2022-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04371393 on ClinicalTrials.gov