Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study
Abstract Background Despite the intense global research endeavour to improve the treatment of patients with COVID-19, the current therapy remains insufficient, resulting in persisting high mortality. Severe cases are characterised by a systemic inflammatory reaction driven by the release of pro-infl...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06566-5 |
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| author | Sina M. Coldewey Charles Neu Frank Bloos Philipp Baumbach Ulrike Schumacher Michael Bauer Philipp Reuken Andreas Stallmach |
| author_facet | Sina M. Coldewey Charles Neu Frank Bloos Philipp Baumbach Ulrike Schumacher Michael Bauer Philipp Reuken Andreas Stallmach |
| author_sort | Sina M. Coldewey |
| collection | DOAJ |
| description | Abstract Background Despite the intense global research endeavour to improve the treatment of patients with COVID-19, the current therapy remains insufficient, resulting in persisting high mortality. Severe cases are characterised by a systemic inflammatory reaction driven by the release of pro-inflammatory cytokines such as IL-6 and tumour-necrosis-factor alpha (TNF-α). TNF-α-blocking therapies have proved beneficial in patients with chronic inflammatory diseases and could therefore pose a new treatment option in COVID-19. Hitherto, no results from randomised controlled trials assessing the effectiveness and safety of infliximab—a monoclonal antibody targeting TNF-α—in the treatment of COVID-19 have been published. Methods In this phase-2 clinical trial, patients with COVID-19 and clinical and laboratory signs of hyperinflammation will be randomised to receive either one dose of infliximab (5 mg/kg body weight) in addition to the standard of care or the standard of care alone. The primary endpoint is the difference in 28-day mortality. Further assessments concern the safety of infliximab therapy in COVID-19 and the influence of infliximab on morbidity and the course of the disease. For the supplementary scientific programme, blood and urine samples are collected to assess concomitant molecular changes. The Ethics Committee of the Friedrich Schiller University Jena (2021-2236-AMG-ff) and the Paul-Ehrlich-Institute (4513/01) approved the study. Discussion The results of this study could influence the therapy of patients with COVID-19 and affect the course of the disease worldwide, as infliximab is globally available and approved by several international drug agencies. Trial registration The trial was registered at clinicaltrials.gov ( NCT04922827 , 11 June 2021) and at EudraCT ( 2021-002098-25 , 19 May 2021). |
| first_indexed | 2024-04-12T23:26:53Z |
| format | Article |
| id | doaj.art-34beb32da3c94f5899ab2e84b899b71a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T23:26:53Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-34beb32da3c94f5899ab2e84b899b71a2022-12-22T03:12:23ZengBMCTrials1745-62152022-09-0123111010.1186/s13063-022-06566-5Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical studySina M. Coldewey0Charles Neu1Frank Bloos2Philipp Baumbach3Ulrike Schumacher4Michael Bauer5Philipp Reuken6Andreas Stallmach7Department of Anaesthesiology and Intensive Care Medicine, Jena University HospitalDepartment of Anaesthesiology and Intensive Care Medicine, Jena University HospitalDepartment of Anaesthesiology and Intensive Care Medicine, Jena University HospitalDepartment of Anaesthesiology and Intensive Care Medicine, Jena University HospitalCentre for Clinical Studies, Jena University HospitalDepartment of Anaesthesiology and Intensive Care Medicine, Jena University HospitalClinic for Internal Medicine IV, Jena University HospitalClinic for Internal Medicine IV, Jena University HospitalAbstract Background Despite the intense global research endeavour to improve the treatment of patients with COVID-19, the current therapy remains insufficient, resulting in persisting high mortality. Severe cases are characterised by a systemic inflammatory reaction driven by the release of pro-inflammatory cytokines such as IL-6 and tumour-necrosis-factor alpha (TNF-α). TNF-α-blocking therapies have proved beneficial in patients with chronic inflammatory diseases and could therefore pose a new treatment option in COVID-19. Hitherto, no results from randomised controlled trials assessing the effectiveness and safety of infliximab—a monoclonal antibody targeting TNF-α—in the treatment of COVID-19 have been published. Methods In this phase-2 clinical trial, patients with COVID-19 and clinical and laboratory signs of hyperinflammation will be randomised to receive either one dose of infliximab (5 mg/kg body weight) in addition to the standard of care or the standard of care alone. The primary endpoint is the difference in 28-day mortality. Further assessments concern the safety of infliximab therapy in COVID-19 and the influence of infliximab on morbidity and the course of the disease. For the supplementary scientific programme, blood and urine samples are collected to assess concomitant molecular changes. The Ethics Committee of the Friedrich Schiller University Jena (2021-2236-AMG-ff) and the Paul-Ehrlich-Institute (4513/01) approved the study. Discussion The results of this study could influence the therapy of patients with COVID-19 and affect the course of the disease worldwide, as infliximab is globally available and approved by several international drug agencies. Trial registration The trial was registered at clinicaltrials.gov ( NCT04922827 , 11 June 2021) and at EudraCT ( 2021-002098-25 , 19 May 2021).https://doi.org/10.1186/s13063-022-06566-5COVID-19Infectious diseasesRespiratory infectionsMolecular diagnosticsRandomised controlled trial |
| spellingShingle | Sina M. Coldewey Charles Neu Frank Bloos Philipp Baumbach Ulrike Schumacher Michael Bauer Philipp Reuken Andreas Stallmach Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study Trials COVID-19 Infectious diseases Respiratory infections Molecular diagnostics Randomised controlled trial |
| title | Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study |
| title_full | Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study |
| title_fullStr | Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study |
| title_full_unstemmed | Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study |
| title_short | Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study |
| title_sort | infliximab in the treatment of patients with severe covid 19 inflixcovid protocol for a randomised controlled multicentre open label phase ii clinical study |
| topic | COVID-19 Infectious diseases Respiratory infections Molecular diagnostics Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-022-06566-5 |
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