Contact Person From COVID-19 Confirmed Patient
Conditions
Keywords
Postexposure prophylaxis, hydroxychloroquine, SARS-CoV-2, COVID-19
Brief summary
There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2. * Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group. * Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment). * Safety comparison: Safety verification by identifying major side effects in the HCQ group.
Interventions
DRUGHydroxychloroquine as post exposure prophylaxis
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
OTHEROthers(No intervention)
No treatment. Close monitoring and quarantine.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* A contact person from confirmed case of SARS-CoV-2 infection * Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals * Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc. * Subjects of study include both symptomatic and asymptomatic contacts.
Exclusion criteria
* Hypersensitivity to Chloroquine or Hydroxychloroquine * Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc. * Human immunodeficiency virus (HIV) infected person * Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease) * Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis) * Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2 * A person who is positive in the COVID-19 screening PCR test before starting PEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of COVID-19 | PCR test of COVID-19 at 14 days after the contact from confirmed case | After postexposure prophylaxis, the rate of COVID-19 conversion between two groups |
Countries
South Korea
Outcome results
None listed