Prohylaxis with hydroxichloroquine aiming at prevention of COVID-19 for medical care workers
- Conditions
- COVID-19 infection
- Registration Number
- JPRN-jRCTs051200060
- Lead Sponsor
- Kakeya Hiroshi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serious adverse events during the drug administration period
- Secondary Outcome Measures
Name Time Method Safety<br>1)Serious adverse events during the post-administration period<br>2)All grade of adverse events during the drug administration period<br>Efficacy<br>1)Incidence of COVID-19<br>2)Seroposivity<br>3)seroconversion rate<br>4)PCR positivity