Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04334148 |
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Recruitment Status :
Completed
First Posted : April 6, 2020
Last Update Posted : February 21, 2021
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Sponsor:
Adrian Hernandez
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Adrian Hernandez, Duke University
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Hydroxychloroquine Drug: Placebo oral tablet | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1363 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double blind, placebo-controlled, randomized clinical trial. |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Double-blind |
| Primary Purpose: | Prevention |
| Official Title: | Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial) |
| Actual Study Start Date : | April 22, 2020 |
| Actual Primary Completion Date : | January 9, 2021 |
| Actual Study Completion Date : | January 9, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Health Facilities
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Hydroxychloroquine
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
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Drug: Hydroxychloroquine
oral self administered tablet
Other Name: Plaquenil |
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Placebo Comparator: Placebo
Matching placebo tablets
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Drug: Placebo oral tablet
oral self administered tablet |
Primary Outcome Measures :
- Number of participants with clinical infection with COVID-19 infection [ Time Frame: 30 days ]Number of participants with clinical infection with COVID-19 infection(hydroxychloroquine vs placebo)
Secondary Outcome Measures :
- Number of participants with COVID-19 viral shedding [ Time Frame: 30 days ]Number of participants with COVID-19 infection shedding (hydroxychloroquine vs placebo)
- Safety as measured by number of adverse events [ Time Frame: 30 days ]Safety as measured by number of adverse events (hydroxychloroquine vs placebo)
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion:
- 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")
Exclusion Criteria:
- 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
- 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
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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
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): NCT04334148
Locations
Show 34 study locations
Sponsors and Collaborators
Adrian Hernandez
Patient-Centered Outcomes Research Institute
Investigators
| Principal Investigator: | Adrian Hernandez, MD | Duke University |
| Responsible Party: | Adrian Hernandez, Professor of Medicine, Duke University |
| ClinicalTrials.gov Identifier: | NCT04334148 |
| Other Study ID Numbers: |
Pro00105274 |
| First Posted: | April 6, 2020 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Adrian Hernandez, Duke University:
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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 Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Chloroquine Chloroquine diphosphate |
Additional relevant MeSH terms:
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Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |