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Inhaled GM-CSF for Respiratory Virus-Associated Severe Pneumonia

NCT02601365 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-06-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2019-05-31
Completion
2019-05-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601365 on ClinicalTrials.gov