Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine
Intervention description: Weekly treatment in individuals at high risk
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hydroxychloroquine

Summary:

      In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks
      in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with
      high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection
      via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will
      receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt
      not to receive the study drug will form the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent

          2. Healthcare workers with

             • One day or more of exposure to suspect and/or positive COVID-19 patients, including
             but not limited to those working in the Emergency Department or Intensive Care Unit.

             OR

             • Unprotected exposure to a known positive COVID-19 patient within 72 hours of
             screening.

          3. Afebrile with no constitutional symptoms

          4. Willing and able to comply with scheduled visits, treatment plan, and other study
             procedures

          5. Evidence of a personally signed and dated informed consent document indicating that
             the subject (or a legally acceptable representative) has been informed of all
             pertinent aspects of the study prior to initiation of any subject-mandated procedures

        Exclusion Criteria:

          1. Participation in other investigational clinical trials for the treatment or prevention
             of SARS-COV-2 infection within 30days

          2. Unwilling to practice acceptable methods of birth control (both males who have
             partners of childbearing potential and females of childbearing potential) during
             Screening, while taking study drug, and for at least 30 days after the last dose of
             study drug is ingested Note: the following criteria follow standard clinical practice
             for FDA approved indications of this medication

          3. Having a prior history of blood disorders such as aplastic anemia, agranulocytosis,
             leukopenia, or thrombocytopenia

          4. Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

          5. Having dermatitis, psoriasis or porphyria

          6. Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and
             kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs,
             antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas,
             amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine,
             praziquantel, Pyridostigmine, tamoxifen citrate

          7. Allergies: 4-Aminoquinolines

          8. Pre-existing retinopathy of the eye

          9. Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated
             hepatitis

         10. Untreated or uncontrolled active bacterial, fungal infection

         11. Known or suspected active drug or alcohol abuse, per investigator judgment

         12. Women who are pregnant or breastfeeding

         13. Known hypersensitivity to any component of the study drug

         14. A known history of prolonged QT syndrome or history of additional risk factors for
             torsades de pointe (e.g., heart failure, requires a lab test , family history of Long
             QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval