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

• Status: Withdrawn
• Trial end date: 2020-06-29
• Target enrollment: 0
• Participant gender: All

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."

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gangnam Severance Hospital
• Treatments: Hydroxychloroquine

Criteria

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