臨床研究等提出・公開システム

Scientific Title	A prospective multi-center open trial to evaluate the safety and efficacy of triple combination therapy of lopinavir , ritonavir and hydroxychloroquine sulfate in patients infected with COVID-19.
Public Title	Triple combination therapy in patients infected with COVID-19

Completion date	June. 02, 2021
Result actual enrolment	0
Baseline Characteristics	Since there were no cases enrolled, baseline characteristics on the subjects could not be obtained.
Participant flow	Since the efficacy of lopinavir, ritonavir, and hydroxychloroquine sulfate was not shown in the research reports from overseas, the recruitment was suspended on June 2, 2020 without any cases. Since there were no cases after that, it was discontinued on June 2, 2021 and ended on the same date (June 2, 2021).
Adverse events	Since there were no cases enrolled, no illness occurred.
Outcome measures	Since the efficacy of lopinavir, ritonavir, and hydroxychloroquine sulfate was not shown in the research reports from overseas, the recruitment was suspended on June 2, 2020 without any cases. No results were obtained after that because there were no cases.
Brief summary	Since the efficacy of lopinavir, ritonavir, and hydroxychloroquine sulfate was not shown in the research reports from overseas, the recruitment was suspended on June 2, 2020 without any cases. No results were obtained after that because there were no cases.
Date of posting of results summaries	July. 20, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No plan to share IPD.
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs031190227

Contact for Scientific Queries	Name	Tokue Yutaka
	Affiliation	Gunma Universty Hospital
	Address	3-39-15 Showa-mchi, Maebashi-shi,Gunma
	Telephone	+81-27-220-8549
	E-mail	tokue49@gmail.com
Contact for Public Queries	Name	Nakamura Tetsuya
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-mchi, Maebashi-shi,Gunma
	Telephone	+81-27-220-8740
	E-mail	nakamurt@gunma-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2020
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	positive result for COVID-19 detection test fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan hospital admission
	Exclusion Criteria	past history of hypersensitivity to lopinavir, ritonavir, hydroxychloroquine or oseltamivir pregnancy
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		patients infected with COVID-19
Intervention(s)		oral administration of lopinavir, ritonavir and hydroxychloroquine with or without oseltamivir
Health Condition(s) Keyword		Coronavirus
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		expected value and 95% CI of ratio of C-reactive protein before versus after the treatment
Secondary Outcome(s)		disappearance rate of COVID-19

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-mchi, Maebashi-shi,Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 26, 2020

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history