Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Treatments: Hydroxychloroquine

Criteria

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