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NCT05266001 · ClinicalTrials.gov registry record · Phase 3
GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
A Phase 3 study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
NCT05266001 is a Phase 3 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 141 participants.
The verdict
NCT05266001, a Phase 3 study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
Study Summary
The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.
Interventions
- OTHER Placebo
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2025-09-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05266001
The ClinicalTrials.gov registry entry for NCT05266001 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05266001 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05266001 about?
NCT05266001 is a clinical study titled "GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS". The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.
What is the current status of trial NCT05266001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2022-06-14. Estimated completion is 2025-09-10.
What interventions are being tested in trial NCT05266001?
The interventions under investigation include: Placebo (OTHER), GM-CSF (DRUG).
Who is sponsoring clinical trial NCT05266001?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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