COVID-19 Clinical Trial
Official title:
Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial
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.
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,
hydroxychloquine 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).
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