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NCT04371393 · ClinicalTrials.gov registry record · Phase 3
MSCs in COVID-19 ARDS
A Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 223
- Enrollment target
NCT04371393: Clinical Trial Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04371393 is a Phase 3 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 223 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04371393, a Phase 3 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 223 participants
- Enrollment target
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.
Primary Outcome
Number of all-cause mortality within 30 days of randomization.
Interventions
- DRUG Placebo
- BIOLOGICAL Remestemcel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2022-01-02 |
| Phase | Phase 3 |
Why NCT04371393 stopped before completion
NCT04371393 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04371393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04371393 about?
NCT04371393 is a clinical study titled "MSCs in COVID-19 ARDS". 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-inflammat...
What is the current status of trial NCT04371393?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2020-04-30. Estimated completion is 2022-01-02.
What interventions are being tested in trial NCT04371393?
The interventions under investigation include: Placebo (DRUG), Remestemcel-L (BIOLOGICAL).
Who is sponsoring clinical trial NCT04371393?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04371393's enrollment target sits among peer trials
223 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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