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

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

ArmDescriptionAssigned Intervention
Active Comparator
Hydroxychloroquine
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
  • Drug: Hydroxychloroquine
    oral self administered tablet
    Other names:
    • Plaquenil
Placebo Comparator
Placebo
Matching placebo tablets
  • Drug: Placebo oral tablet
    oral self administered tablet

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Mario Castro, MD
mcastro2@kumc.edu

More Details

Status
Recruiting
Sponsor
Adrian Hernandez

Study Contact

Rachel Olson, RN
919-668-5590
rachel.e.olson@duke.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.