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

JRCT ID: jRCTs051200060

Registered date:25/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19 infection
• Date of first enrollment: 25/09/2020
• Target sample size: 500
• Study type: Interventional
• Intervention(s): One or two tables of hydroxychloroquine sulfate 200mg once in a day, after meal, oral, for 7 days

Outcome(s)

• Primary Outcome: Serious adverse events during the drug administration period

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kakeya Hiroshi
• Secondary Sponsor: Kaneko Akira,University Public Corporation Osaka, OsakaCity University