Inhaled GM-CSF for Respiratory Virus-Associated Severe Pneumonia

Phase 1

Withdrawn

• Conditions: Acute Respiratory Distress Syndrome; Pneumonia; Respiratory Virus Infection
• Interventions: Drug: Sargramostim 0.04 mcg/kg/dose; Drug: Sargramostim 0.2mcg/kg/dose; Drug: Sargramostim 1 mcg/kg/dose

• Registration Number: NCT02601365
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

This study will investigate the safety and efficacy of the administration of inhaled GM-CSF to patients with respiratory virus-associated pneumonia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-10
• Study Start: 2019-03
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerosolized Sargramostim	Sargramostim 0.04 mcg/kg/dose	A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
Aerosolized Sargramostim	Sargramostim 0.2mcg/kg/dose	A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization
Aerosolized Sargramostim	Sargramostim 1 mcg/kg/dose	A self-controlled, open-label study to evaluate safety of Sargramostim administered by nebulization

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events of Inhaled Sargramostim in Adult Patients with Severe Respiratory Viral Pneumonia	1 year	The occurrence of any treatment-emergent Adverse Events (AE's) or Serious Adverse Events (SAE's) will be recorded over the course of the trial.