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Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial
Introduction Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases. Patients/Methods This randomised, double-blind exploratory study (EudraCT number 2020-00377...
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| Published in: | Advances in therapy 2022-06, Vol.39 (6), p.3011-3018 |
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| container_title | Advances in therapy |
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| creator | Dreher, Michael Grohè, Christian Hartmann, Niels-Ulrik Kanzler, Stephan Kraft, Karin Sarrazin, Christoph Doll, Michael Spiesshöfer, Jens Steiner, Stephan Wöhrle, Jochen Seeger, Julia Röschmann-Doose, Kristina Thomsen, Jörn Wittig, Thomas Marx, Nikolaus Eisenmann, Stephan |
| description | Introduction
Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases.
Patients/Methods
This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days’ add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency.
Results
The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (
p
= 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (
p
= 0.0035), required less supplemental oxygen (
p
= 0.0229), and were more often without dyspnoea when climbing stairs at home (
p
|
| doi_str_mv | 10.1007/s12325-022-02135-z |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9007397</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2650254927</sourcerecordid><originalsourceid>FETCH-LOGICAL-c397t-a34119fc80050f2f086601ae53002ba504dbe18b30d017a0b6bcce5087381c643</originalsourceid><addsrcrecordid>eNp9kctuEzEUhi0EoqHwAiyQl2wMx_Z4LiyQojRApKBUJSB2lsfjaVxNxoPtKUwfiyfEIaGCDYsjWzr_-c_lQ-g5hVcUoHgdKONMEGAsBeWC3D1AM1rmgqRgD9EMiowSxsuvZ-hJCDcADApRPkZnXGS0ygXM0M9l21qt9IRV3-BPqjVxwq7Fy_XmI4ESsAp43jRk0-Ptzng1TNj2eLH5srogtMKXKlrTx4C_27jDcz1Gg69MGKxX0fkJr_owHhokkZ7e4OWPoXOn1IWKCrfe7XHcGXzpXRiMjvY2_TulTe3IwvXRu64zzaHh_GqFt96q7il61KoumGen9xx9frfcLj6Q9eb9ajFfE82rIhLFM0qrVpcAAlrWQpnnQJURPN2hVgKypja0rDk0QAsFdV5rbQSUBS-pzjN-jt4efYex3ptGpz296uTg7V75STpl5b-Z3u7ktbuVVYKTRkgGL08G3n0bTYhyb4M2Xad648YgWSLARFaxg5QdpTrdIXjT3rehIA-w5RG2TLDlb9jyLhW9-HvA-5I_dJOAHwUhpfpr4-WNG32fjvY_218Xu7ac</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2650254927</pqid></control><display><type>article</type><title>Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial</title><source>Springer Link</source><source>Alma/SFX Local Collection</source><creator>Dreher, Michael ; Grohè, Christian ; Hartmann, Niels-Ulrik ; Kanzler, Stephan ; Kraft, Karin ; Sarrazin, Christoph ; Doll, Michael ; Spiesshöfer, Jens ; Steiner, Stephan ; Wöhrle, Jochen ; Seeger, Julia ; Röschmann-Doose, Kristina ; Thomsen, Jörn ; Wittig, Thomas ; Marx, Nikolaus ; Eisenmann, Stephan</creator><creatorcontrib>Dreher, Michael ; Grohè, Christian ; Hartmann, Niels-Ulrik ; Kanzler, Stephan ; Kraft, Karin ; Sarrazin, Christoph ; Doll, Michael ; Spiesshöfer, Jens ; Steiner, Stephan ; Wöhrle, Jochen ; Seeger, Julia ; Röschmann-Doose, Kristina ; Thomsen, Jörn ; Wittig, Thomas ; Marx, Nikolaus ; Eisenmann, Stephan</creatorcontrib><description>Introduction
Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases.
Patients/Methods
This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days’ add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency.
Results
The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (
p
= 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (
p
= 0.0035), required less supplemental oxygen (
p
= 0.0229), and were more often without dyspnoea when climbing stairs at home (
p
< 0.0001).
Conclusion
These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.</description><identifier>ISSN: 0741-238X</identifier><identifier>ISSN: 1865-8652</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-022-02135-z</identifier><identifier>PMID: 35419650</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Brief Report ; Cardiology ; COVID-19 - complications ; Double-Blind Method ; Dyspnea - drug therapy ; Dyspnea - etiology ; Endocrinology ; Humans ; Internal Medicine ; Medicine ; Medicine & Public Health ; Oncology ; Pharmacology/Toxicology ; Prospective Studies ; Respiratory Insufficiency - drug therapy ; Rheumatology ; SARS-CoV-2 ; Treatment Outcome</subject><ispartof>Advances in therapy, 2022-06, Vol.39 (6), p.3011-3018</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c397t-a34119fc80050f2f086601ae53002ba504dbe18b30d017a0b6bcce5087381c643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35419650$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dreher, Michael</creatorcontrib><creatorcontrib>Grohè, Christian</creatorcontrib><creatorcontrib>Hartmann, Niels-Ulrik</creatorcontrib><creatorcontrib>Kanzler, Stephan</creatorcontrib><creatorcontrib>Kraft, Karin</creatorcontrib><creatorcontrib>Sarrazin, Christoph</creatorcontrib><creatorcontrib>Doll, Michael</creatorcontrib><creatorcontrib>Spiesshöfer, Jens</creatorcontrib><creatorcontrib>Steiner, Stephan</creatorcontrib><creatorcontrib>Wöhrle, Jochen</creatorcontrib><creatorcontrib>Seeger, Julia</creatorcontrib><creatorcontrib>Röschmann-Doose, Kristina</creatorcontrib><creatorcontrib>Thomsen, Jörn</creatorcontrib><creatorcontrib>Wittig, Thomas</creatorcontrib><creatorcontrib>Marx, Nikolaus</creatorcontrib><creatorcontrib>Eisenmann, Stephan</creatorcontrib><title>Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial</title><title>Advances in therapy</title><addtitle>Adv Ther</addtitle><addtitle>Adv Ther</addtitle><description>Introduction
Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases.
Patients/Methods
This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days’ add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency.
Results
The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (
p
= 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (
p
= 0.0035), required less supplemental oxygen (
p
= 0.0229), and were more often without dyspnoea when climbing stairs at home (
p
< 0.0001).
Conclusion
These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.</description><subject>Brief Report</subject><subject>Cardiology</subject><subject>COVID-19 - complications</subject><subject>Double-Blind Method</subject><subject>Dyspnea - drug therapy</subject><subject>Dyspnea - etiology</subject><subject>Endocrinology</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Oncology</subject><subject>Pharmacology/Toxicology</subject><subject>Prospective Studies</subject><subject>Respiratory Insufficiency - drug therapy</subject><subject>Rheumatology</subject><subject>SARS-CoV-2</subject><subject>Treatment Outcome</subject><issn>0741-238X</issn><issn>1865-8652</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kctuEzEUhi0EoqHwAiyQl2wMx_Z4LiyQojRApKBUJSB2lsfjaVxNxoPtKUwfiyfEIaGCDYsjWzr_-c_lQ-g5hVcUoHgdKONMEGAsBeWC3D1AM1rmgqRgD9EMiowSxsuvZ-hJCDcADApRPkZnXGS0ygXM0M9l21qt9IRV3-BPqjVxwq7Fy_XmI4ESsAp43jRk0-Ptzng1TNj2eLH5srogtMKXKlrTx4C_27jDcz1Gg69MGKxX0fkJr_owHhokkZ7e4OWPoXOn1IWKCrfe7XHcGXzpXRiMjvY2_TulTe3IwvXRu64zzaHh_GqFt96q7il61KoumGen9xx9frfcLj6Q9eb9ajFfE82rIhLFM0qrVpcAAlrWQpnnQJURPN2hVgKypja0rDk0QAsFdV5rbQSUBS-pzjN-jt4efYex3ptGpz296uTg7V75STpl5b-Z3u7ktbuVVYKTRkgGL08G3n0bTYhyb4M2Xad648YgWSLARFaxg5QdpTrdIXjT3rehIA-w5RG2TLDlb9jyLhW9-HvA-5I_dJOAHwUhpfpr4-WNG32fjvY_218Xu7ac</recordid><startdate>20220601</startdate><enddate>20220601</enddate><creator>Dreher, Michael</creator><creator>Grohè, Christian</creator><creator>Hartmann, Niels-Ulrik</creator><creator>Kanzler, Stephan</creator><creator>Kraft, Karin</creator><creator>Sarrazin, Christoph</creator><creator>Doll, Michael</creator><creator>Spiesshöfer, Jens</creator><creator>Steiner, Stephan</creator><creator>Wöhrle, Jochen</creator><creator>Seeger, Julia</creator><creator>Röschmann-Doose, Kristina</creator><creator>Thomsen, Jörn</creator><creator>Wittig, Thomas</creator><creator>Marx, Nikolaus</creator><creator>Eisenmann, Stephan</creator><general>Springer Healthcare</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220601</creationdate><title>Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial</title><author>Dreher, Michael ; Grohè, Christian ; Hartmann, Niels-Ulrik ; Kanzler, Stephan ; Kraft, Karin ; Sarrazin, Christoph ; Doll, Michael ; Spiesshöfer, Jens ; Steiner, Stephan ; Wöhrle, Jochen ; Seeger, Julia ; Röschmann-Doose, Kristina ; Thomsen, Jörn ; Wittig, Thomas ; Marx, Nikolaus ; Eisenmann, Stephan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c397t-a34119fc80050f2f086601ae53002ba504dbe18b30d017a0b6bcce5087381c643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Brief Report</topic><topic>Cardiology</topic><topic>COVID-19 - complications</topic><topic>Double-Blind Method</topic><topic>Dyspnea - drug therapy</topic><topic>Dyspnea - etiology</topic><topic>Endocrinology</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Oncology</topic><topic>Pharmacology/Toxicology</topic><topic>Prospective Studies</topic><topic>Respiratory Insufficiency - drug therapy</topic><topic>Rheumatology</topic><topic>SARS-CoV-2</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dreher, Michael</creatorcontrib><creatorcontrib>Grohè, Christian</creatorcontrib><creatorcontrib>Hartmann, Niels-Ulrik</creatorcontrib><creatorcontrib>Kanzler, Stephan</creatorcontrib><creatorcontrib>Kraft, Karin</creatorcontrib><creatorcontrib>Sarrazin, Christoph</creatorcontrib><creatorcontrib>Doll, Michael</creatorcontrib><creatorcontrib>Spiesshöfer, Jens</creatorcontrib><creatorcontrib>Steiner, Stephan</creatorcontrib><creatorcontrib>Wöhrle, Jochen</creatorcontrib><creatorcontrib>Seeger, Julia</creatorcontrib><creatorcontrib>Röschmann-Doose, Kristina</creatorcontrib><creatorcontrib>Thomsen, Jörn</creatorcontrib><creatorcontrib>Wittig, Thomas</creatorcontrib><creatorcontrib>Marx, Nikolaus</creatorcontrib><creatorcontrib>Eisenmann, Stephan</creatorcontrib><collection>SpringerOpen (Open Access)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dreher, Michael</au><au>Grohè, Christian</au><au>Hartmann, Niels-Ulrik</au><au>Kanzler, Stephan</au><au>Kraft, Karin</au><au>Sarrazin, Christoph</au><au>Doll, Michael</au><au>Spiesshöfer, Jens</au><au>Steiner, Stephan</au><au>Wöhrle, Jochen</au><au>Seeger, Julia</au><au>Röschmann-Doose, Kristina</au><au>Thomsen, Jörn</au><au>Wittig, Thomas</au><au>Marx, Nikolaus</au><au>Eisenmann, Stephan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Ther</stitle><addtitle>Adv Ther</addtitle><date>2022-06-01</date><risdate>2022</risdate><volume>39</volume><issue>6</issue><spage>3011</spage><epage>3018</epage><pages>3011-3018</pages><issn>0741-238X</issn><issn>1865-8652</issn><eissn>1865-8652</eissn><abstract>Introduction
Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases.
Patients/Methods
This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days’ add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency.
Results
The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (
p
= 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (
p
= 0.0035), required less supplemental oxygen (
p
= 0.0229), and were more often without dyspnoea when climbing stairs at home (
p
< 0.0001).
Conclusion
These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>35419650</pmid><doi>10.1007/s12325-022-02135-z</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Advances in therapy, 2022-06, Vol.39 (6), p.3011-3018 |
| issn | 0741-238X 1865-8652 1865-8652 |
| language | eng |
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| source | Springer Link; Alma/SFX Local Collection |
| subjects | Brief Report Cardiology COVID-19 - complications Double-Blind Method Dyspnea - drug therapy Dyspnea - etiology Endocrinology Humans Internal Medicine Medicine Medicine & Public Health Oncology Pharmacology/Toxicology Prospective Studies Respiratory Insufficiency - drug therapy Rheumatology SARS-CoV-2 Treatment Outcome |
| title | Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial |
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