Canakinumab to reduce deterioration of cardiac and respiratory function in SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury : The three C study)
© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC..
BACKGROUND: In patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation.
HYPOTHESIS: The primary hypothesis is that canakiumab will shorten time to recovery.
METHODS: The three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period.
RESULTS: Baseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
CONCLUSIONS: The three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
Clinical cardiology - 43(2020), 10 vom: 18. Okt., Seite 1055-1063 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sheng, Calvin C [VerfasserIn] |
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| Links: |
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| Themen: |
37CQ2C7X93 |
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| Anmerkungen: |
Date Completed 10.12.2020 Date Revised 12.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/clc.23451 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM314045023 |
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| 100 | 1 | |a Sheng, Calvin C |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Canakinumab to reduce deterioration of cardiac and respiratory function in SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury |b The three C study) |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Completed 10.12.2020 | ||
| 500 | |a Date Revised 12.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND: In patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation | ||
| 520 | |a HYPOTHESIS: The primary hypothesis is that canakiumab will shorten time to recovery | ||
| 520 | |a METHODS: The three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period | ||
| 520 | |a RESULTS: Baseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury | ||
| 520 | |a CONCLUSIONS: The three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Covid-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a canakinumab | |
| 650 | 4 | |a myocardial injury | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Biomarkers |2 NLM | |
| 650 | 7 | |a canakinumab |2 NLM | |
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| 700 | 1 | |a Wang, Tom Kai Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Abou Hassan, Ossama K |e verfasserin |4 aut | |
| 700 | 1 | |a Brennan, Danielle |e verfasserin |4 aut | |
| 700 | 1 | |a Culver, Daniel A |e verfasserin |4 aut | |
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| 700 | 1 | |a Nissen, Steven E |e verfasserin |4 aut | |
| 700 | 1 | |a Menon, Venu |e verfasserin |4 aut | |
| 700 | 1 | |a Cremer, Paul C |e verfasserin |4 aut | |
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