臨床研究実施計画・研究概要公開システム

Japanease

Date of registration	Sept. 25, 2020
Last modified on	April. 15, 2021
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

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

Date of first enrollment		Sept. 25, 2020
Target sample size		500
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control
	assignment	parallel assignment
	purpose	prevention purpose
Countries of Recruitment（Except Japan）		none
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) Code
Intervention(s) Keyword		Hydroxychloroquine
Intervention(s)		One or two tables of hydroxychloroquine sulfate 200mg once in a day, after meal, oral, for 7 days
Health Condition(s) Code		006
Health Condition(s) Keyword		COVID-19 infection
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

Recruitment status	Pending

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

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority