Aug. 18, 2020 |
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Aug. 13, 2021 |
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jRCT2021200018 |
An exploratory Phase II investigator-initiated clinical trial of the efficacy and safety of TM5614 in patients with SARS-CoV-2 pneumonia(COVID-19) |
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An exploratory Phase II investigator-initiated clinical trial of the efficacy and safety of TM5614 in patients with novel coronavirus pneumonia |
Harigae Hideo |
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Tohoku University Hospital |
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1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi |
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+81-22-717-7162 |
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r187chiken@crieto.hosp.tohoku.ac.jp |
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Clinical Trial Coordinating Office |
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Clinical Research, Innovation and Education Center, Tohoku University Hospital |
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1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi |
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+81-22-717-7136 |
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r187chiken@crieto.hosp.tohoku.ac.jp |
Complete |
July. 20, 2020 |
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Oct. 07, 2020 | ||
30 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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(1) Inpatients over the age of 20 obtained by written consent |
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(1) Patients on home oxygen therapy |
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20age old over | ||
No limit | ||
Both |
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novel coronavirus (SARS-CoV-2) pneumonia |
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TM5614 is started at 120 mg once daily for a 14-day period. On Day 7, it will be confirmed whether the drug could be increased and in case determined that the dose could be increased, the dose will be increased to 180 mg from the next day. However, if bleeding symptoms, liver dysfunction are seen on Day 7, or if it is considered impossible to increase the dose to 180 mg, the dose will be continued at 120 mg. |
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novel coronavirus pneumonia, novel coronavirus infection |
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Drug Therapy |
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Existence of deterioration of oxygenation requiring ventilator management |
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1. Survival for 28 days from the start of study drug administration |
Japan Agency for Medical Research and Development | |
Not applicable |
Institutional Review Board of Tohoku University Hospital | |
1-1 Seiryo-machi, Aoba-ku, Sendai, , Miyagi | |
+81-22-717-7056 |
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chiken@grp.hosp.tohoku.ac.jp | |
Approval | |
June. 24, 2020 |
No |
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none |