Contact Person From COVID-19 Confirmed PatientPhase 3COVID-19NCT04330144
Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
A Phase 3 study testing Hydroxychloroquine as post exposure prophylaxis in people with Contact Person From COVID-19 Confirmed Patient, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Person From COVID-19 Confirmed Patient
- What is being tested?
- Hydroxychloroquine as post exposure prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 29 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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."
- Being tested
- Hydroxychloroquine as post exposure prophylaxis, Others(No intervention)
- Keywords
- Postexposure prophylaxis, hydroxychloroquine, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine as post exposure prophylaxisDrug
1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
Others(No intervention)Other
No treatment. Close monitoring and quarantine.
| Study group | Role | What they receive |
|---|---|---|
| administration of hydroxychloroquine as PEP | Experimental | Not described Receives: Drug: Hydroxychloroquine as post exposure prophylaxis |
| control with no PEP | Active comparator | Not described Receives: Other: Others(No intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of COVID-19
After postexposure prophylaxis, the rate of COVID-19 conversion between two groups
Measured: PCR test of COVID-19 at 14 days after the contact from confirmed case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Person From COVID-19 Confirmed PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Goo Song, Gangnam Severance Hospital
- Investigators
- Yong Goo Song, Professor, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330144
- Sponsor's protocol ID
- 3-2020-0036
- Acronym
- COVID-19
- Status last verified
- Aug 2021
- First submitted
- 30 Mar 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
- ClinicalTrials.gov ID
- NCT04330144
- Acronym / sponsor ID
- COVID-19 / 3-2020-0036
- Keywords
- Postexposure prophylaxis, hydroxychloroquine, SARS-CoV-2, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| administration of hydroxychloroquine as PEP | Experimental | Drug: Hydroxychloroquine as post exposure prophylaxis |
| control with no PEP | Active comparator | Other: Others(No intervention) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine as post exposure prophylaxis1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po | Drug | administration of hydroxychloroquine as PEP |
| Others(No intervention)No treatment. Close monitoring and quarantine. | Other | control with no PEP |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Goo Song, Professor principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine as post exposure prophylaxis in people with Contact Person From COVID-19 Confirmed Patient, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of COVID-19 (time frame: PCR test of COVID-19 at 14 days after the contact from confirmed case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.