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

Columbia University

Status and phase

Terminated

Phase 3

Phase 2

Conditions

COVID-19

Corona Virus Infection

Treatments

Drug: Hydroxychloroquine

Drug: Placebo oral tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04318444

AAAS9676

Details and patient eligibility

About

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.

Full 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 fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%). Interventions to decrease the incidence and severity of COVID-19 are emergently needed.

Hydroxychloroquine (brand name, Plaquenil), an inexpensive anti-malarial medication with immunomodulatory effects, is a promising therapy for COVID-19. Chloroquine, a related compound with a less favorable toxicity profile, has shown benefit in clinical studies conducted in approximately one-hundred SARS-CoV-2 infected patients. In vitro, hydroxychloroquine has been recently shown to have greater efficacy against SARS-CoV-2 versus chloroquine.

Currently, there is no established post-exposure prophylaxis for persons at high risk of developing COVID-19. Hydroxychloroquine (brand name, Plaquenil), is a medicine that has been found to be effective against the novel coronavirus in some recent experiments. Previously, hydroxychloroquine has been safety used to prevent malaria or to treat autoimmune diseases.

This study will test if hydroxychloroquine may be used to prevent the development of COVID-19 symptoms in persons who live with an individual who has been diagnosed with COVID-19. If hydroxychloroquine is shown to reduce the risk of developing symptoms of COVID-19 among people at high risk of infection, this could help to reduce the morbidity and mortality of the COVID-19 epidemic.

This is a trial of hydroxychloroquine PEP among adult household contacts of COVID-19 patients in New York City (NYC). The trial will be initiated at NewYork-Presbyterian (NYP)/Columbia University Irving Medical Center (CUIMC).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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