Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
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ClinicalTrials.gov Identifier: NCT04334148 |
Recruitment Status :
Completed
First Posted : April 6, 2020
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Hydroxychloroquine Drug: Placebo oral tablet | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
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 |
Placebo Comparator: Placebo
Matching placebo tablets
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Drug: Placebo oral tablet
oral self administered tablet |
- 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)
- 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)

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 |
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
-
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

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

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 |
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 |
Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |