Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Condition: Corona Virus Infection; Acute Respiratory Distress Syndrome; SARS-CoV Infection; Coronavirus; Coronavirus Infections
MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Hydroxychloroquine; Placebo
Intervention description: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days; 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Asymptomatic participants are randomized and analyzed separate from symptomatic participants.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Corona Virus; SARS-COV-2; Coronavirus

Summary:

      Study Objective:

        1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic
           COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.

        2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression
           in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and
           symptom severity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent

          -  Exposure to a COVID19 case within 4 days as either a household contact or occupational
             exposure, OR

          -  Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR
             symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom
             onset;

        Exclusion Criteria:

          -  Current hospitalization

          -  Allergy to hydroxychloroquine

          -  Retinal eye disease

          -  Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

          -  Known chronic kidney disease, stage 4 or 5 or receiving dialysis

          -  Structural or ischemic heart disease

          -  Personal or Family History of Prolonged QT syndrome

          -  Weight < 50 kg

          -  Known Porphyria

          -  Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor;
             amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or
             Procan, Procanbid, propafenone, Rythmal, sotalol;

          -  Current use of medicines which prolong the QT interval including:

               -  Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin,
                  clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine

               -  Antidepressants: amitriptyline, citalopram, desipramine, escitalopram,
                  imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine

               -  Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine,
                  thioridazine, ziprasidone

               -  Methadone

               -  Sumatriptan, zolmitriptan