COVID-19Phase 3HCQPrePNCT04363450
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
A Phase 3 study testing Hydroxychloroquine in people with COVID-19 and Corona Virus Infection, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
Trial summary
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Corona Virus Infection, Wuhan Coronavirus
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,700 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2020to 1 Jun 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Healthcare or Hospital Worker who has direct patient contact
- Willing to participate in the research.
- Able to understand and sign the informed consent form
Who cannot join
- Age < 18 years
- History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics
- Known prolonged QTc interval
- History of retinal disease
- Kidney failure with GFR <10%
- Chronic hepatic disease w/ Child-Pugh class B or C
Show all 10Show fewer
- Hypersensitivity to chloroquine or hydroxychloroquine
- Currently taking chloroquine or hydroxychloroquine
- Unwilling to participate
- Unable to understand and/or sign the informed consent form.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Lafayette General Medical Center
Lafayette, Louisiana, 70503
Ann D Chauffe, DO, MPH, 337-261-6000, achauf@lsuhsc.edu
Rebecca B Lee, DO, MS
- Recruiting
University Hospital and Clinics
Lafayette, Louisiana, 70506
Ann D Chauffe, DO, MPH, 337-261-6000, achauf@lsuhsc.edu
Ann D Chauffe, DO, MPH
About this study
Official title: Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
Read the detailed description
The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic COVID-19 infection. The secondary objectives are number of days absent from work due to symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting of >50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). The study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.
- Conditions
- COVID-19, Corona Virus Infection, Wuhan Coronavirus, Prophylaxis, Healthcare Worker, Sars-CoV2
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- COVID-19, COVID-19 Prophylaxis, Healthcare Workers, SARS-COV-2, Hydroxychloroquine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called HCQ PreP
Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
PlaceboDrug
Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial. Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | An identical placebo will be administered on an identical dosing interval and frequency. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic COVID-19 infection in healthcare workers
Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
Measured: 12 weeks
Secondary outcomes (2)
Absenteeism from work due to COVID-19
Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
Measured: 12 weeks
Severity of COVID-19 infection
Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Apr 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Model description
- Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Lafayette General Health, University of Louisiana at Lafayette
- Responsible party
- Principal investigator, Ann Chauffe, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363450
- Sponsor's protocol ID
- LSU NO HSC IRB 20-050
- Acronym
- HCQPreP
- Status last verified
- Aug 2020
- First submitted
- 23 Apr 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
- ClinicalTrials.gov ID
- NCT04363450
- Acronym / sponsor ID
- HCQPreP / LSU NO HSC IRB 20-050
- Conditions
- COVID-19, Corona Virus Infection, Wuhan Coronavirus, Prophylaxis, Healthcare Worker, Sars-CoV2
- Keywords
- COVID-19, COVID-19 Prophylaxis, Healthcare Workers, SARS-COV-2, Hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Lafayette General Health, University of Louisiana at Lafayette
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 27 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.
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
Detailed description
The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic COVID-19 infection. The secondary objectives are number of days absent from work due to symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting of >50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). The study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineHydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial. |
| Placebo | Placebo comparator | Drug: PlaceboAn identical placebo will be administered on an identical dosing interval and frequency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Healthcare or Hospital Worker who has direct patient contact
- Willing to participate in the research.
- Able to understand and sign the informed consent form
Key exclusion criteria (10 listed)
- Age < 18 years
- History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics
- Known prolonged QTc interval
- History of retinal disease
- Kidney failure with GFR <10%
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 |
|---|---|---|
| HydroxychloroquineAlso: HCQ PrePHydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly | Drug | Hydroxychloroquine |
| PlaceboLoading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly | Drug | Placebo |
Primary outcome
Incidence of symptomatic COVID-19 infection in healthcare workers
Time frame: 12 weeks
Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
2 secondary outcomes
Absenteeism from work due to COVID-19
Time frame: 12 weeks
Severity of COVID-19 infection
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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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.
2 sites 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 in people with COVID-19 and Corona Virus Infection, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
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 10 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann D. Chauffe, DO, MPH (337-261-6161, achauf@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic COVID-19 infection in healthcare workers (time frame: 12 weeks). 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 2 Sep 2020.