Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)
The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.
Conditions:
🦠 COVID-19 🦠 Corona Virus Infection
🗓️ Study Start (Actual) 29 March 2020
🗓️ Primary Completion (Estimated) March 2021
✅ Study Completion (Estimated) March 2022
👥 Enrollment (Estimated) 1600
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Household contact of index case: currently residing in the same household as an individual evaluated at NYP via outpatient, emergency department (ED), or inpatient services who (1) test positive for COVID-19, or (2) are defined as suspected cases, or persons under investigations (PUI), by the treating physician.
    • * Willing to take study drug as directed for 5 days.

    Exclusion Criteria:

    • * Age \<18 years old
    • * Suspected or confirmed current COVID-19, defined as: (1) temperature \> 38 Celsius; (2) cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5) positive confirmatory testing for COVID-19
    • * Suspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks.
    • * Inability to take medications orally
    • * Inability to provide written consent
    • * Known sensitivity/allergy to hydroxychloroquine
    • * Current use of hydroxychloroquine for another indication
    • * Pregnancy
    • * Prior diagnosis of retinopathy
    • * Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
    • * Major comorbidities increasing risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2020
  • First Submitted that Met QC Criteria 20 March 2020
  • First Posted 24 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2020
  • Last Update Posted 27 April 2020
  • Last Verified April 2020