Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial) (COVID-19)

Yonsei University Health System (YUHS)

Status and phase: Withdrawn; Phase 3

Conditions: Contact Person From COVID-19 Confirmed Patient

Treatments: Drug: Hydroxychloroquine as post exposure prophylaxis; Other: Others(No intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT04330144

3-2020-0036

Details and patient eligibility

About

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."

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

administration of hydroxychloroquine as PEP

Experimental group

Treatment:

Drug: Hydroxychloroquine as post exposure prophylaxis

control with no PEP

Active Comparator group

Treatment:

Other: Others(No intervention)