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Completed Phase 3 Interventional

GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

ClinicalTrials.gov ID: NCT05266001

Public ClinicalTrials.gov record NCT05266001. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05266001
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
141 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Day to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 14, 2022 (Actual)
Primary completion
Sep 10, 2025 (Actual)
Completion
Sep 10, 2025 (Actual)
Last update posted
Apr 9, 2026

2022 – 2025

United States locations

U.S. sites
25
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Children's Hospital of Los Angeles Los Angeles California 90027 —
Benioff Children's Hospital - Oakland Oakland California 64609 —
Children's Hospital of Orange County Orange California 92868 —
University of California - Davis Sacramento California 95618 —
Benioff Children's Hospital - Mission Bay San Francisco California 94143 —
Children's Hospital Colorado Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
CS Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Hospital of Michigan Detroit Michigan 48202 —
Children's Hospital of Minnesota Minneapolis Minnesota 55404 —
University of Minnesota Minneapolis Minnesota 55455 —
Mercy Children's Hospital Kansas City Missouri 64108 —
Duke University Durham North Carolina 27705 —
Rainbow Babies and Children's Hospital Cleveland Ohio 44106 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Pennsylvania State University Hershey Pennsylvania 17033 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15260 —
Medical University of South Carolina Charleston South Carolina 29425 —
Texas Children's Hospital Houston Texas 77030 —
Children's Hospital of San Antonio San Antonio Texas 78207 —
Primary Children's Hospital Salt Lake City Utah 84158 —
Virginia Commonwealth University Richmond Virginia 23298 —
Medical College of Wisconsin Milwaukee Wisconsin 53233 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05266001, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 9, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05266001 live on ClinicalTrials.gov.

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