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

Y

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Withdrawn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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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