Japanease

July. 27, 2020

July. 27, 2020

jRCTs051200036

Efficacy and safety of nintedanib on lung fibrosis in severe pneumonia induced by coronavirus disease 2019: Historical control study.

Efficacy of nintedanib on severe COVID-19 pneumonia.

Umemura Yutaka

Osaka Genaral Medical Center

3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka

+81-6-6692-1201

plum0022@yahoo.co.jp

Umemura Yutaka

Osaka

3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka

+81-6-6692-1201

plum0022@yahoo.co.jp

July. 27, 2020

30

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

none

1) Obtaining sufficient informed consent for this trials from participates or their close relatives
2) 20 years or older at the time of informed consent
3) Confirmed COVID-19 by PCR assay or LAMP assay
4) Respiratory failure requiring mechanical ventilation
5) Availability of a nasogastric tube

1) History of Idiopathic pulmonary fibrosis
2) History of chronic liver failure (Child Pugh B or C)
3) Breastfeeding and pregnancy
4) History or proven risk factors of thrombosis
5) Proven risk factors of bleeding
6) Unavailable to use enteral tube
7) Ineligibility for other reasons

20age 0month 0week old over
No limit

Both

Severe pneumonia induced by COVID-19

nintedanib

nintedanib

Administration of nintedanib via nasogastric tube

COVID-19

COVID-19

28 days mortality after the initiation of mechanical ventilation

1) Gastrointestinal adverse events within 28 days after adiministration of nintedanib
2) Liver failure within 28 days after adiministration of nintedanib
3) P/F ratio and KL-6, 14 days and 28 days after the initiation of mechanical ventilation

Recruiting

Osaka General Medical Center, Funding for research projects
Not applicable
Institutional Review Board for Clinical Research of Osaka General Medical center
3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka, Osaka

+81-6-6692-1201

kenkyu-crb@gh.opho.jp
Approval

July. 08, 2020