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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318444
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jon T. Giles, Columbia University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 2 Phase 3

Detailed 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, 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial
Actual Study Start Date : March 29, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
 Drug: Hydroxychloroquine
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
Other Name: Plaquenil
Placebo Comparator: Placebo
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
 Drug: Placebo oral tablet
Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with symptomatic, lab-confirmed COVID-19. [ Time Frame: Date of enrollment to 14 days post-enrollment date ]
    This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318444


Contacts
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Contact: Jon T. Giles, MD 212-305-2447 jtg2122@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jon T. Giles, MD    212-305-2447    jtg2122@cumc.columbia.edu   
Principal Investigator: Jon T. Giles, MD         
Sub-Investigator: Elizabeth Oelsner, MD, MPH         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jon T. Giles, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jon T. Giles, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT04318444    
Other Study ID Numbers: AAAS9676
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents