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

August 2, 2021 updated by: Young Goo Song, Gangnam Severance Hospital

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

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."

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
PCR test of COVID-19 at 14 days after the contact from confirmed case

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Yong Goo Song, Professor, Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ACTUAL)

June 29, 2020

Study Completion (ACTUAL)

June 29, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (ACTUAL)

April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2020-0036

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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