臨床研究等提出・公開システム

Japanese

Date of registration	May. 20, 2020
Last modified on	May. 09, 2024
Trial ID	jRCTs061200002

Scientific Title	Randomized controlled trial of teprenone for preventing aggravation of COVID-19
Public Title	Teprenone for preventing aggravation of COVID-19

Contact for Scientific Queries	Name	ICHIHARA Eiki
	Affiliation	Okayama University Hospital
	Address	2-5-1, Shikata-cho, Kita-ku, Okayama
	Telephone	+81-86-235-7227
	E-mail	ichiha-e@md.okayama-u.ac.jp
Contact for Public Queries	Name	ICHIHARA Eiki
	Affiliation	Okayama University Hospital
	Address	2-5-1, Shikata-cho, Kita-ku, Okayama
	Telephone	+81-86-235-7227
	E-mail	ichiha-e@md.okayama-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 20, 2020
Actual date of first enrollment		July. 15, 2020
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. 20 years-old or older 2. Confirmed diagnosis of COVID-19 with PCR or antigen test 3. temperature >= 37.5 degree Celsius 4. All subjects are required to have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study
	Exclusion Criteria	1. Teprenon use within 2 weeks of study treatment 2. Patient who needs ventilator or ECMO 3. Active infectious disease requiring systemic treatment except for stable NTM 4. During pregnancy, within 28 days of postparturition, or during lactation. 5. Unidentified patient
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Intervention(s)		Teprenone 50mg p.o. 3 times a day after each meal for 10 days
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Intubation rate
Secondary Outcome(s)		1. Mortality 2. Period until fever relief 3. Oxygen dose 4. Change in chest CT images 5. Blood test values and theire rate of change 6. Severity 7. Period until discharge or lifting quarantine restrictions 8. Period until symptom disappearance 9. Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Okayama University
Secondary Sponsor	Not applicable

Name of Certified Review Board	Okayama University Certified Review Board
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Okayama
Telephone	+81-86-235-7133
E-Mail	ouh-crrb@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	April. 28, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	May. 09, 2024	(this page)	Changes
5	Oct. 26, 2023	Detail	Changes
4	Sept. 16, 2021	Detail	Changes
3	May. 20, 2021	Detail	Changes
2	Oct. 15, 2020	Detail	Changes
1	May. 20, 2020	Detail

List of change history