University of Utah COVID-19 Hydrochloroquine Trial
Condition: Coronavirus Infection; Coronavirus; Infectious Disease
MeSH terms: COVID-19; Coronavirus Infections; Communicable Diseases; Infections
Intervention: Hydroxychloroquine; Placebo oral tablet
Intervention description: HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days; Placebo to be taken on the same schedule as HCQ.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2, prospective, placebo-controlled, parallel group, randomized trial
Masking: None (Open Label)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronavirus; COVID-19; hydrochloroquine; placebo

Summary:

      A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has
      reached 160 countries, infecting over 500,000 individuals and killing more than 24,000
      people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as
      COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in
      hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have
      been symptomatic for 5-7 days prior to admission, indicating that there is a window during
      which an effective intervention could significantly alter the course of illness, lessen
      disease spread, and alleviate the stress on hospital resources.

      There is no known treatment for COVID-19, though in vitro and one poorly controlled study
      have identified a potential antiviral activity for HCQ. The rationale for this clinical trial
      is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and
      shedding in adult outpatients with confirmed COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age ≥18 years, competent to provide consent

          -  Within 48 hours of positive nucleic acid test for SARS-CoV-2

        Exclusion Criteria:

          -  Patient already prescribed chloroquine or hydroxychloroquine

          -  Allergy to hydroxychloroquine

          -  History of bone marrow or solid organ transplant

          -  Known G6PD deficiency

          -  Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or
             Glomerular Filtration Rate < 20ml/min/1.73m2

          -  Known liver disease (e.g. Child Pugh score ≥ B or AST>2 times upper limit)

          -  Psoriasis

          -  Porphyria

          -  Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications
             known to prolong QT interval

          -  Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone

          -  Seizure disorder

          -  Prisoner

          -  Weight < 35kg

          -  Inability to follow-up - no cell phone or no address or not Spanish or English
             speaking

          -  Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or
             trial related) within the 30 days prior to the time of the screening evaluation

          -  Patient or another member of patient's household has been already enrolled in this
             study.