臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 25, 2020
Last modified on	May. 09, 2022
Trial ID	jRCTs051200060

Scientific Title	Evaluation of safety and efficacy of post exposure prophylaxis with hydroxychloroquine aiming at prevention of COVID-19 for medical care workers
Public Title	Prohylaxis with hydroxichloroquine aiming at prevention of COVID-19 for medical care workers

Completion date	Feb. 28, 2022
Result actual enrolment	0
Baseline Characteristics	No participant is enrolled.
Participant flow	Since all the papers reported so far on the preventive effe ct of hydroxychloroquine on COVID-19 are negative, and s ince the WHO has announced that it does not recommend the use of hydroxychloroquine as a prophylactic agent for covid-19, we concluded to cancel the study.
Adverse events	None.
Outcome measures	No data.
Brief summary	Since all the papers reported so far on the preventive effe ct of hydroxychloroquine on COVID-19 are negative, and s ince the WHO has announced that it does not recommend the use of hydroxychloroquine as a prophylactic agent for covid-19, we concluded to cancel the study.
Date of posting of results summaries	Mar. 31, 2022
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Not planned.
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs051200060

Contact for Scientific Queries	Name	Kakeya Hiroshi
	Affiliation	Osaka City University hospital
	Address	1-4-3, Asahicho, Abeno, Osaka, Osaka
	Telephone	+81-6-6645-3784
	E-mail	kakeya@med.osaka-cu.ac.jp
Contact for Public Queries	Name	Kaneko Akira
	Affiliation	University Public Corporation Osaka, Osaka City University
	Address	1-4-3, Asahicho, Abeno, Osaka, Osaka
	Telephone	+81-6-6645-3760
	E-mail	akira555@med.osaka-cu.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 25, 2020
Actual date of first enrollment
Target sample size		500
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Male or female with age 18 or greater at the time of consent (2) Is able to administrate the drug orally (3) Is able to follow the schedule for medical exam defined in the research protocol (4) Has provided written consent for participation The participants from age 18 to 20 have to provide written consents from both the subject and a legal guardian The participants are not limited to the workers who involve in infection control zone
	Exclusion Criteria	(1) History of COVID-19 (2) History of allergy for hydroxychroloquine (3) weight less than 31kg (4) Under medication with the drugs which are listed as contraindications for coadministration with HCQ (5) History of retinopathy or macular degeneration (6) Pregnant or planning pregnancy (7) Breastfeeding (8) Performance status of 2 or greater (9) Advanced liver function abnormalities classified as grade C by the Child-Pugh criteria (10) Renal disease classified CKD stage more than 4 (11) Allergy for quinine (12) G-6-PD dificiency (13) Porphyria (14) scabies (15) Under medication with gastrointestinal/neural/hematologic disorders (16) Risk for ophthalmopathy (17) Ventricular arrhythmia (18) History of long QTc (19) Deemed ineligible as determined by the principal investigator or a co-investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19 infection
Intervention(s)		One or two tables of hydroxychloroquine sulfate 200mg once in a day, after meal, oral, for 7 days
Health Condition(s) Keyword		COVID-19 infection
Intervention(s) Keyword		Hydroxychloroquine
Health Condition(s) Code		006
Intervention(s) Code
Primary Outcome(s)		Serious adverse events during the drug administration period
Secondary Outcome(s)		Safety 1) Serious adverse events during the post-administration period 2) All grade of adverse events during the drug administration period Efficacy 1) Incidence of COVID-19 2) Seroposivity 3) seroconversion rate 4) PCR positivity

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	University Public Corporation Osaka, OsakaCity University
Secondary Sponsor	Applicable

Name of Certified Review Board	Osaka City University Hospital Certified Review Board
Address	Abeno Medics 5F, 1-2-7, Asahicho, Abeno, Osaka, Osaka, Osaka
Telephone	+81-6-6645-3456
E-Mail	irb@med.osaka-cu.ac.jp
Approval Status	Approval
Date of approval	Sept. 16, 2020

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	May. 09, 2022	(this page)	Changes
5	May. 20, 2021	Detail	Changes
4	April. 15, 2021	Detail	Changes
3	Mar. 17, 2021	Detail	Changes
2	Nov. 12, 2020	Detail	Changes
1	Sept. 25, 2020	Detail

List of change history