Oct. 12, 2020 |
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Feb. 08, 2021 |
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jRCT2071200041 |
Prevention of aggravation of mechanical ventilation required pneumonia caused by COVID - 19 using adrenomedullin - Investigator initiated phase 2a trial (AM-P2-COVID) |
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Therapeutic development of adrenomedullin for severe pneumonia caused by COVID-19 |
Kita Toshihiro |
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Faculty of Medicine, University of Miyazaki |
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5200 Kihara, Kiyotake, Miyazaki, Miyazaki |
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+81-895-85-0872 |
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toshihiro_kita@med.miyazaki-u.ac.jp |
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Kita Toshihiro |
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Faculty of Medicine, University of Miyazaki |
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5200 Kihara, Kiyotake, Miyazaki, Miyazaki |
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+81-895-85-0872 |
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toshihiro_kita@med.miyazaki-u.ac.jp |
Recruiting |
Nov. 01, 2020 |
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Nov. 25, 2020 | ||
40 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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patients with mechanical ventilation required pneumonia caused by COVID-19 |
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patients with liver dysfunction (AST and/or ALT > 5 times of reference values) |
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20age old over | ||
75age old under | ||
Both |
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COVID-19 |
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Intravenous infusion of investigative drug (adrenomedullin or placebo) will be started immediately after the introduction of mechanical ventilation. The administration of the drug are maintained 72 hour and then intermittent administration (8 hours per day) are followed up to 10 days. The drug administration will be stop after withdrawal of mechanical ventilation. |
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Period of mechanical ventilation (days) |
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the distribution of clinical status assessed on the 6-point ordinal scale on study day 15 and 30 |
Japan Agency for Medical Research and Development | |
Institutional Review Board of the University of Miyazaki | |
5200 Kihara, Kiyotake, Miyazaki, Miyazaki | |
+81-985-85-9852 |
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chiken-jimu@med.miyazaki-u.ac.jp | |
Approval | |
No |
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none |