NCT02601365

Inhaled GM-CSF for Respiratory Virus-Associated Severe Pneumonia

A Phase I Study of Inhaled GM-CSF in the Treatment of Respiratory Virus-associated Severe Pneumonia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Respiratory Distress Syndrome
• Pneumonia
• Respiratory Virus Infection

Interventions

Type	Name	Description
DRUG	Sargramostim 0.04 mcg/kg/dose	The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.04 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
DRUG	Sargramostim 0.2mcg/kg/dose	The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.2 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
DRUG	Sargramostim 1 mcg/kg/dose	The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 1 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-11-10
• Last updated: 2023-06-02

Regulatory

• FDA-regulated drug study