NCT04569877|CompletedPhase 2
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia
GI-COVID
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)
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GI-COVID
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
63
1 country
9
Study Start
September 24, 2020
Actual (reported)Primary Completion
June 21, 2022
Actual (reported)Study Completion
September 20, 2022
Actual (reported)To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2020
Actual (reported)September 25, 2020
Actual (reported)September 30, 2020
Actual (reported)June 21, 2022
Actual (reported)September 20, 2022
Actual (reported)Mechanical ventilation
Need for mechanical ventilation within 15 days after randomization
During 15 days
Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale):
At day 15 and day 29
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
At day 0 (day before first dose), day 1-9, and day 15
Oxygen supply
At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15
Clinical parameter: temperature
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
Clinical parameter: blood pressure
Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15
300μg molgramostim nebuliser solution
Placebo nebuliser solution
300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system
Placebo nebulised seven times within 7 days via rapid nebuliser system
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, 60488, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen
Giessen, 35392, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Arndt CA, Koshkina NV, Inwards CY, Hawkins DS, Krailo MD, Villaluna D, Anderson PM, Goorin AM, Blakely ML, Bernstein M, Bell SA, Ray K, Grendahl DC, Marina N, Kleinerman ES. Inhaled granulocyte-macrophage colony stimulating factor for first pulmonary recurrence of osteosarcoma: effects on disease-free survival and immunomodulation. a report from the Children's Oncology Group. Clin Cancer Res. 2010 Aug 1;16(15):4024-30. doi: 10.1158/1078-0432.CCR-10-0662. Epub 2010 Jun 24.
Ballinger MN, Paine R 3rd, Serezani CH, Aronoff DM, Choi ES, Standiford TJ, Toews GB, Moore BB. Role of granulocyte macrophage colony-stimulating factor during gram-negative lung infection with Pseudomonas aeruginosa. Am J Respir Cell Mol Biol. 2006 Jun;34(6):766-74. doi: 10.1165/rcmb.2005-0246OC. Epub 2006 Feb 10.
Susanne Herold, Prof. Dr.
Universitätsklinikum Giessen und Marburg (UKGM)
63 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2020
First Posted
September 30, 2020
Study Start
September 24, 2020
Actual (reported)Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Sana Klinikum Offenbach
Offenbach, 63069, Germany
Cakarova L, Marsh LM, Wilhelm J, Mayer K, Grimminger F, Seeger W, Lohmeyer J, Herold S. Macrophage tumor necrosis factor-alpha induces epithelial expression of granulocyte-macrophage colony-stimulating factor: impact on alveolar epithelial repair. Am J Respir Crit Care Med. 2009 Sep 15;180(6):521-32. doi: 10.1164/rccm.200812-1837OC. Epub 2009 Jul 9.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Hamilton JA. Colony-stimulating factors in inflammation and autoimmunity. Nat Rev Immunol. 2008 Jul;8(7):533-44. doi: 10.1038/nri2356.
Herold S, Hoegner K, Vadasz I, Gessler T, Wilhelm J, Mayer K, Morty RE, Walmrath HD, Seeger W, Lohmeyer J. Inhaled granulocyte/macrophage colony-stimulating factor as treatment of pneumonia-associated acute respiratory distress syndrome. Am J Respir Crit Care Med. 2014 Mar 1;189(5):609-11. doi: 10.1164/rccm.201311-2041LE. No abstract available.
Huang FF, Barnes PF, Feng Y, Donis R, Chroneos ZC, Idell S, Allen T, Perez DR, Whitsett JA, Dunussi-Joannopoulos K, Shams H. GM-CSF in the lung protects against lethal influenza infection. Am J Respir Crit Care Med. 2011 Jul 15;184(2):259-68. doi: 10.1164/rccm.201012-2036OC. Epub 2011 Apr 7.
LeVine AM, Reed JA, Kurak KE, Cianciolo E, Whitsett JA. GM-CSF-deficient mice are susceptible to pulmonary group B streptococcal infection. J Clin Invest. 1999 Feb;103(4):563-9. doi: 10.1172/JCI5212.
Matute-Bello G, Liles WC, Radella F 2nd, Steinberg KP, Ruzinski JT, Hudson LD, Martin TR. Modulation of neutrophil apoptosis by granulocyte colony-stimulating factor and granulocyte/macrophage colony-stimulating factor during the course of acute respiratory distress syndrome. Crit Care Med. 2000 Jan;28(1):1-7. doi: 10.1097/00003246-200001000-00001.
Papiris SA, Tsirigotis P, Kolilekas L, Papadaki G, Papaioannou AI, Triantafillidou C, Papaporfyriou A, Karakatsani A, Kagouridis K, Griese M, Manali ED. Long-term inhaled granulocyte macrophage-colony-stimulating factor in autoimmune pulmonary alveolar proteinosis: effectiveness, safety, and lowest effective dose. Clin Drug Investig. 2014 Aug;34(8):553-64. doi: 10.1007/s40261-014-0208-z.
Presneill JJ, Harris T, Stewart AG, Cade JF, Wilson JW. A randomized phase II trial of granulocyte-macrophage colony-stimulating factor therapy in severe sepsis with respiratory dysfunction. Am J Respir Crit Care Med. 2002 Jul 15;166(2):138-43. doi: 10.1164/rccm.2009005.
Primary Completion
June 21, 2022
Actual (reported)Study Completion
September 20, 2022
Actual (reported)Last Updated
May 10, 2023
Record last verified: 2022-06
Study protocol will be provided after publication
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Source: ClinicalTrials.gov.
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