Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Purpose
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
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double blind, placebo-controlled, randomized clinical trial.
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Double-blind
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Hydroxychloroquine |
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30. |
|
Placebo Comparator Placebo |
Matching placebo tablets |
|
More Details
- Status
- Completed
- Sponsor
- Adrian Hernandez
Study Contact
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.