Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Condition: COVID-19
Intervention: Hydroxychloroquine; Placebo oral tablet
Intervention description: oral self administered tablet; oral self administered tablet
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
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
Enrollment: 1360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
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; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Chloroquine; Chloroquine diphosphate

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.
    

Eligibility 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