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

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ClinicalTrials.gov Identifier: NCT04569877
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Giessen

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

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome (SARS) Pneumonia COVID-19 Pneumonia Drug: Molgramostim nebuliser solution Other: Placebo nebuliser solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : December 25, 2022
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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
Placebo nebuliser solution
Other: Placebo nebuliser solution
Placebo nebulised seven times within 7 days via rapid nebuliser system




Primary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: During 15 days ]
    Need for mechanical ventilation within 15 days after randomization


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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%

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  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)

  10. 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)

  11. 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)

  12. 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)

  13. Bacterial pneumonia [ Time Frame: At day 0, day 1-7, day 8-9 and day 15 ]
    Occurrence of secondary bacterial pneumonia

  14. Vaso-active drugs [ Time Frame: At day 29 ]
    Days on vaso-active drugs in a 29-day period

  15. Mortality [ Time Frame: At day 29 ]
    All-cause mortality

  16. GM-CSF [ Time Frame: At day 0 and day 1-7 ]
    GM-CSF levels in serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569877


Contacts
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Contact: Susanne Herold, Prof. Dr. +49 (0) 641 985 57061 Susanne.Herold@innere.med.uni-giessen.de
Contact: Nelli Ens-Jäger +49 (0) 6421 282 6598 nelli.ens@kks.uni-marburg.de

Locations
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Germany
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Martin Kolditz, PD Dr. med.         
Principal Investigator: Martin Kolditz, PD Dr. med.         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Oliver Witzke, Prof. Dr. med.         
Principal Investigator: Oliver Witzke, Prof. Dr. med.         
Krankenhaus Nordwest GmbH Recruiting
Frankfurt am Main, Germany, 60488
Contact: Ulrich Dessureault         
Principal Investigator: Ulrich Dessureault         
Universitätsklinikum Frankfurt Recruiting
Frankfurt am Main, Germany, 60590
Contact: Maria Vehreschild, Prof. Dr.         
Principal Investigator: Maria Vehreschild, Prof. Dr.         
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Recruiting
Gießen, Germany, 35392
Contact: Susanne Herold, Prof. Dr.         
Principal Investigator: Susanne Herold, Prof. Dr         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Tobias Welte, Prof. Dr.         
Principal Investigator: Tobias Welte, Prof. Dr.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Felix Herth, Prof. Dr.         
Principal Investigator: Felix Herth, Prof. Dr.         
Lungenfachklinik Immenhausen Recruiting
Immenhausen, Germany, 34376
Contact: Stefan Andreas, Prof. Dr.         
Principal Investigator: Stefan Andreas, Prof. Dr.         
Sana Klinikum Offenbach Recruiting
Offenbach am Main, Germany, 63069
Contact: André Althoff, Dr. med.         
Principal Investigator: André Althoff, Dr. med.         
Sponsors and Collaborators
University of Giessen
Investigators
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Principal Investigator: Susanne Herold, Prof. Dr. Universitätsklinikum Giessen und Marburg (UKGM)
Publications:

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Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04569877    
Other Study ID Numbers: KKS-279
2020-001654-21 ( EudraCT Number )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol will be provided after publication
Supporting Materials: Study Protocol
Time Frame: 3 Months after publication
Access Criteria: Central server

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Giessen:
GM-CSF
COVID-19
ARDS
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Molgramostim
Pharmaceutical Solutions
Sargramostim
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs