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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051200060
Enrollment
500
Registered
2020-09-25
Start date
2020-09-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection COVID-19 infection

Interventions

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

Sponsors

Kakeya Hiroshi
Lead Sponsor
Kaneko Akira
Collaborator
University Public Corporation Osaka, OsakaCity University
Collaborator

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Serious adverse events during the drug administration period

Secondary

MeasureTime frame
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

Contacts

Public ContactAkira Kaneko

University Public Corporation Osaka, Osaka City University

akira555@med.osaka-cu.ac.jp+81-6-6645-3760

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026