Skip to main content
OpenTrials
Completed

NCT Number: NCT04569877

GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Acute Respiratory Syndrome (SARS) Pneumonia COVID-19 COVID-19 Pneumonia Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent form by the patient according to local regulations
  • Man or non-pregnant woman
  • Age ≥18 years
  • 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 *.
  • 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
  • Negative serum pregnancy test in women of childbearing potentia

Exclusion criteria

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

Treatment and study plan

Molgramostim nebuliser solution

Drug

300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system

Placebo nebuliser solution

Other

Placebo nebulised seven times within 7 days via rapid nebuliser system

Primary outcomes

  1. Mechanical ventilation

    Time frame: During 15 days

    Need for mechanical ventilation within 15 days after randomization

Secondary outcomes

  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

    • Not hospitalized, no limitations on activities
    • Not hospitalized, limitation on activities;
    • Hospitalized, not requiring supplemental oxygen;
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, on invasive mechanical ventilation or ECMO;
    • 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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Acronym: GI-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2020
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.