Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330144
Recruitment Status : Not yet recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Young Goo Song, Gangnam Severance Hospital

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."

Condition or disease Intervention/treatment Phase
Contact Person From COVID-19 Confirmed Patient Drug: Hydroxychloroquine as post exposure prophylaxis Other: Others(No intervention) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: administration of hydroxychloroquine as PEP Drug: Hydroxychloroquine as post exposure prophylaxis
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po

Active Comparator: control with no PEP Other: Others(No intervention)
No treatment. Close monitoring and quarantine.




Primary Outcome Measures :
  1. The rate of COVID-19 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330144


Contacts
Layout table for location contacts
Contact: Yong Goo Song, Professor 82-2-2019-3310 ext 3310 imfell@yuhs.ac

Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yong Goo Song, Professor Gangnam Severance Hospital
Layout table for additonal information
Responsible Party: Young Goo Song, Professor, Department of Internal Medicine,, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04330144    
Other Study ID Numbers: 3-2020-0036
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Young Goo Song, Gangnam Severance Hospital:
Postexposure prophylaxis
hydroxychloroquine
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents