Status:
TERMINATED
Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)
Lead Sponsor:
Columbia University
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 suspec...
Detailed Description
COVID-19 is a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fift...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04318444
Start Date
March 29 2020
End Date
March 31 2021
Last Update
September 25 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032