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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitätsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Giessen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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