COVID-19Phase 3HERO-HCQNCT04334148
Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
A Phase 3 study testing Hydroxychloroquine in people with COVID-19, run by Adrian Hernandez at 34 sites in United States.
Trial summary
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days. 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
- 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
- 1,360 participants
- Where
- 34 sitesUnited States
- Study dates
- 22 Apr 2020to 9 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completed Informed Consent
- Age ≥ 18 years old
- Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections ("healthcare worker")
Who cannot join
- Prior diagnosis of COVID-19 infection
- Participation in another COVID-19 prophylaxis trial within 30 days of consent
- Respiratory illness with new-onset fever (Temperature > 100°F) or ongoing cough or dyspnea within 14 days
- Known allergy to HCQ or chloroquine
- Congenital prolonged QT syndrome
- Current or planned use of QT prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications
Show all 19Show fewer
- End stage renal disease
- Pre-existing retinopathy
- Current or planned use of Hydroxychloroquine (study drug) for any indication
- Current or planned use of the following for treatment or prevention of COVID-19 infection:
- Chloroquine
- Azithromycin
- Known cirrhosis or severe liver disease
- History of severe skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis
- History of psoriasis or porphyria
- Ventricular arrhythmias requiring medical treatment
- Severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms
- Current or planned use of use of anti-seizure drugs
- History of Glucose-6-phosphate dehydrogenase deficiency
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Hospital Colorado/University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins
Baltimore, Maryland, 21287
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern Medicine
Chicago, Illinois, 60611
Rush University
Chicago, Illinois, 60612
University of Missouri-Columbia
Columbia, Missouri, 65212
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
University of Florida
Gainesville, Florida, 32610
University of Iowa
Iowa City, Iowa, 52242
University of Florida Jacksonville
Jacksonville, Florida, 32206
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Florida Health Central Florida
Leesburg, Florida, 34748
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449
University of Miami Florida
Miami, Florida, 33136
Allina Health
Minneapolis, Minnesota, 55404
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Hospital for Special Surgery
New York, New York, 10021
Columbia University, Irving Medical Center
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Advent Health
Orlando, Florida, 32804
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Hospital Rochester
Rochester, Minnesota, 55905
Seattle Children's Hospital
Seattle, Washington, 98105
University of South Florida
Tampa, Florida, 33606
Baylor Scott & White Medical Center-Temple
Temple, Texas, 76504
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.
Read the detailed description
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. After enrollment, baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly through a direct to participant portal. A call center will provide support for any missed visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of treatment is 30 days. Participants are followed via survey weekly. At the end of treatment participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from baseline.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Placebo oral tablet
- Keywords
- Hydroxychloroquine, Coronavirus Infections, Novel Coronavirus, Protective agents, Prophylaxis, Chemoprophylaxis, Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, Adult, Acute Lung Injury, Virus Diseases, Lung Diseases, Respiratory Tract Diseases, Respiration Disorders, Lung Injury, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Respiratory Tract Infections, Antimalarials, Antiprotozoal Agents
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, Acute Lung Injury, Virus Diseases, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
oral self administered tablet
Placebo oral tabletDrug
oral self administered tablet
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Matching placebo tablets Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Infection With COVID-19 Infection
This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
Measured: 30 days
Secondary outcomes (2)
Number of Participants With COVID-19 Viral Shedding
Number of participants with COVID-19 infection shedding via Covance swab PCR testing
Measured: 30 days
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start22 Apr 2020
- Primary completion10 Dec 2020
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind, placebo-controlled, randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Hernandez
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Adrian Hernandez, Duke University
- Investigators
- Adrian Hernandez, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334148
- Sponsor's protocol ID
- Pro00105274
- Acronym
- HERO-HCQ
- Status last verified
- Oct 2021
- First submitted
- 2 Apr 2020
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.
Publications
Naggie S, Milstone A, Castro M, Collins SP, Lakshmi S, Anderson DJ, Cahuayme-Zuniga L, Turner KB, Cohen LW, Currier J, Fraulo E, Friedland A, Garg J, George A, Mulder H, Olson RE, O'Brien EC, Rothman RL, Shenkman E, Shostak J, Woods CW, Anstrom KJ, Hernandez AF; HERO Research Program. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ). Int J Infect Dis. 2023 Apr;129:40-48. doi: 10.1016/j.ijid.2023.01.019. Epub 2023 Jan 20.
PubMed 36682681
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
- ClinicalTrials.gov ID
- NCT04334148
- Acronym / sponsor ID
- HERO-HCQ / Pro00105274
- Conditions
- COVID-19
- Keywords
- Hydroxychloroquine, Coronavirus Infections, Novel Coronavirus, Protective agents, Prophylaxis, Chemoprophylaxis, Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- Adrian HernandezUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.
Detailed description
This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. After enrollment, baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly through a direct to participant portal. A call center will provide support for any missed visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of treatment is 30 days. Participants are followed via survey weekly. At the end of treatment participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineHydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletMatching placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed Informed Consent
- Age ≥ 18 years old
- Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections ("healthcare worker")
Key exclusion criteria (19 listed)
- Prior diagnosis of COVID-19 infection
- Participation in another COVID-19 prophylaxis trial within 30 days of consent
- Respiratory illness with new-onset fever (Temperature > 100°F) or ongoing cough or dyspnea within 14 days
- Known allergy to HCQ or chloroquine
- Congenital prolonged QT syndrome
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: Plaqueniloral self administered tablet | Drug | Hydroxychloroquine |
| Placebo oral tabletoral self administered tablet | Drug | Placebo |
Primary outcome
Number of Participants With Clinical Infection With COVID-19 Infection
Time frame: 30 days
This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
2 secondary outcomes
Number of Participants With COVID-19 Viral Shedding
Time frame: 30 days
Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36682681Naggie S, Milstone A, Castro M, Collins SP, Lakshmi S, Anderson DJ, Cahuayme-Zuniga L, Turner KB, Cohen LW, Currier J, Fraulo E, Friedland A, Garg J, George A, Mulder H, Olson RE, O'Brien EC, Rothman RL, Shenkman E, Shostak J, Woods CW, Anstrom KJ, Hernandez AF; HERO Research Program. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ). Int J Infect Dis. 2023 Apr;129:40-48. doi: 10.1016/j.ijid.2023.01.019. Epub 2023 Jan 20.
- Individual participant dataSharing planned: Yes. Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.
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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.
Adrian Hernandez, MD principal investigator
Duke University
34 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, run by Adrian Hernandez at 34 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 3 inclusion and 19 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: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Infection With COVID-19 Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334148, which also lists 1 linked publication.
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 12 Oct 2021.