Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19) (NCT04318444) | Clinical Trial Compass
TerminatedPhase 2/3
Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)
Stopped: The Institutional Review Board closed the study
United States10 participantsStarted 2020-03-29
Plain-language 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 suspected COVID-19 patients.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Number of Participants With Symptomatic, Lab-confirmed COVID-19.
Timeframe: Date of enrollment to 14 days post-enrollment date