Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Corona Virus Infection
  • COVID-19
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 decr...

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).

Tracking Information

NCT #
NCT04318444
Collaborators
Not Provided
Investigators
Principal Investigator: Jon T. Giles, MD Columbia University