GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

May 9, 2023 updated by: University of Giessen

Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat this devastating disease with a mortality rate of up to 50%. The growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote differentiation and mobilization of different myeloid leukocyte subsets including neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Frankfurt am Main, Germany, 60488
        • Krankenhaus Nordwest Gmbh
      • Frankfurt am Main, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Gießen, Germany, 35392
        • Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69126
        • UniversitatsKlinikum Heidelberg
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Offenbach am Main, Germany, 63069
        • Sana Klinikum Offenbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent form by the patient according to local regulations
  2. Man or non-pregnant woman
  3. Age ≥18 years
  4. Willingness of patients with reproductive potential to use highly effective contraceptive methods by practicing abstinence or by using at least two methods of birth control from the date of consent to the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used *.
  5. Lab-confirmed COVID-19 pneumonia where pneumonia is diagnosed by radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam) AND pulse oximeter oxygen saturation ≤ 94% at room air in patients that do not have chronic hypoxia; or less than their baseline oxygenation in patients that suffer from chronic hypoxia
  6. Negative serum pregnancy test in women of childbearing potentia

Exclusion Criteria:

  1. Pregnancy or breast feeding
  2. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
  3. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim (e.g. Leucomax®) or to related compounds (e.g. Leukine®)
  4. Patient not able to use nebulizer device as well as immediately foreseeable mechanical ventilation of the patient
  5. Simultaneous participation in another clinical trial with an experimental treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molgramostim nebuliser solution
300μg molgramostim nebuliser solution
Drug: Molgramostim nebuliser solution
300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system
Placebo Comparator: Placebo nebuliser solution
Other: Placebo nebuliser solution
Placebo nebulised seven times within 7 days via rapid nebuliser system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation
Time Frame: During 15 days
Need for mechanical ventilation within 15 days after randomization
During 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale):
Time Frame: At day 15 and day 29
  1. Not hospitalized, no limitations on activities
  2. Not hospitalized, limitation on activities;
  3. Hospitalized, not requiring supplemental oxygen;
  4. Hospitalized, requiring supplemental oxygen;
  5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
  6. Hospitalized, on invasive mechanical ventilation or ECMO;
  7. Death.
At day 15 and day 29
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: At day 0 (day before first dose), day 1-9, and day 15
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] will be measured at day 0 (day before first dose), day 1-9, and day 15
At day 0 (day before first dose), day 1-9, and day 15
Oxygen supply
Time Frame: At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15
Need for oxygen supply (l/min) to reach peripheral oxygen saturation of 98%
At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15
Clinical parameter: temperature
Time Frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter (4 times daily): temperature (°C degree)
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: blood pressure
Time Frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter (4 times daily): blood pressure (mmHg)
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: heart beat
Time Frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter (4 times daily): hear beat (beats per minute)
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: respiratory rate
Time Frame: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter (4 times daily): respiratory rate (breaths per minute)
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR)
Time Frame: Max. 48 hours before day 0 and at day 8-9
Presence of Severe acute respiratory syndrome coronavirus 2 nucleic acid by PCR test in swabs or tracheal aspirates/bronchoalveolar lavage
Max. 48 hours before day 0 and at day 8-9
Laboratory: C-reactive protein test
Time Frame: At day 0, day 1-7, day 8-9 and day 15
C-reactive protein test measures the amount of C-reactive protein in blood (mg/L)
At day 0, day 1-7, day 8-9 and day 15
Laboratory: ferritin
Time Frame: At day 0, day 1-7, day 8-9 and day 15
Ferritin test measures the amount of ferritin in the blood (ng/ml)
At day 0, day 1-7, day 8-9 and day 15
Laboratory: Interleukin-6
Time Frame: At day 0, day 1-7, day 8-9 and day 15
Interleukin-6 test (IL-6) measures the amount of IL-6 in the blood (pg/ml)
At day 0, day 1-7, day 8-9 and day 15
Laboratory: procalcitonin
Time Frame: At day 0, day 1-7, day 8-9 and day 15
Procalcitonin (PCT) test measures the amount of PCT in the blood in (μg/l)
At day 0, day 1-7, day 8-9 and day 15
Bacterial pneumonia
Time Frame: At day 0, day 1-7, day 8-9 and day 15
Occurrence of secondary bacterial pneumonia
At day 0, day 1-7, day 8-9 and day 15
Vaso-active drugs
Time Frame: At day 29
Days on vaso-active drugs in a 29-day period
At day 29
Mortality
Time Frame: At day 29
All-cause mortality
At day 29
GM-CSF
Time Frame: At day 0 and day 1-7
GM-CSF levels in serum
At day 0 and day 1-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Principal Investigator: Susanne Herold, Prof. Dr., Universitätsklinikum Giessen und Marburg (UKGM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKS-279
  • 2020-001654-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol will be provided after publication

IPD Sharing Time Frame

3 Months after publication

IPD Sharing Access Criteria

Central server

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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