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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: Completed Phase 3 study, sponsored by Nationwide Children's Hospital.
NCT05266001 is a Phase 3 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cumulative Pediatric Logistic Organ Dysfunction (PELOD)-2 score through 28 days post-randomization. The range of PELOD-2 score for a given day is 0 - 33 with a higher number being worse.
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 |
What the finished NCT05266001 record still lists
NCT05266001 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05266001 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05266001's enrollment target sits among peer trials
141 1563rd of 2000 higher than 436 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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