臨床研究実施計画・研究概要公開システム

Japanease

Date of registration	July. 27, 2020
Last modified on	Feb. 25, 2021
Trial ID	jRCTs051200036

Scientific Title	Efficacy and safety of nintedanib on lung fibrosis in severe pneumonia induced by coronavirus disease 2019: Historical control study.
Public Title	Efficacy of nintedanib on severe COVID-19 pneumonia.

Contact for Scientific Queries	Name	Umemura Yutaka
	Affiliation	Osaka Genaral Medical Center
	Address	3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka
	Telephone	+81-6-6692-1201
	E-mail	plum0022@yahoo.co.jp
Contact for Public Queries	Name	Umemura Yutaka
	Affiliation	Osaka
	Address	3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka
	Telephone	+81-6-6692-1201
	E-mail	plum0022@yahoo.co.jp

Date of first enrollment		July. 29, 2020
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Countries of Recruitment（Except Japan）		none
Key inclusion & exclusion criteria	Inclusion Criteria	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
	Exclusion Criteria	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
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Severe pneumonia induced by COVID-19
Intervention(s) Code		nintedanib
Intervention(s) Keyword		nintedanib
Intervention(s)		Administration of nintedanib via nasogastric tube
Health Condition(s) Code		COVID-19
Health Condition(s) Keyword		COVID-19
Primary Outcome(s)		28 days mortality after the initiation of mechanical ventilation
Secondary Outcome(s)		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

Recruitment status	Recruiting

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Osaka General Medical Center, Funding for research projects
Secondary Sponsor	Not applicable

Name of Certified Review Board	Medical Center Clinical Research Review Board
Address	3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka, Osaka
Telephone	+81-6-6692-1201
E-Mail	kenkyu-crb@gh.opho.jp
Approval Status	Approval
Date of approval	July. 08, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority