Japanease

Sept. 25, 2020

April. 15, 2021

jRCTs051200060

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

Prohylaxis with hydroxichloroquine aiming at prevention of COVID-19 for medical care workers

Kakeya Hiroshi

Osaka City University hospital

1-4-3, Asahicho, Abeno, Osaka, Osaka

+81-6-6645-3784

kakeya@med.osaka-cu.ac.jp

Kaneko Akira

University Public Corporation Osaka, Osaka City University

1-4-3, Asahicho, Abeno, Osaka, Osaka

+81-6-6645-3760

akira555@med.osaka-cu.ac.jp

Sept. 25, 2020

500

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control

parallel assignment

prevention purpose

none

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

(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

18age old over
No limit

Both

COVID-19 infection

Hydroxychloroquine

One or two tables of hydroxychloroquine sulfate 200mg once in a day, after meal, oral, for 7 days

006

COVID-19 infection

Serious adverse events during the drug administration period

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

Pending

University Public Corporation Osaka, OsakaCity University
Applicable
Osaka City University Hospital Certified Review Board
Abeno Medics 5F, 1-2-7, Asahicho, Abeno, Osaka, Osaka, Osaka

+81-6-6645-3456

irb@med.osaka-cu.ac.jp
Approval

Sept. 16, 2020

No