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

NCT04318444 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAS9676
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Symptomatic, Lab-confirmed COVID-19.

  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.

  Date of enrollment to 14 days post-enrollment date

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Hydroxychloroquine DRUG

Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.

Also known as: Plaquenil

Hydroxychloroquine

Placebo oral tablet DRUG

Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.

Also known as: Placebo Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.

  PMID: 33570583 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jon T. Giles, MD
• Organization: Columbia University

jtg2122@cumc.columbia.edu

212-305-6327

Study Officials

• Jon T. Giles, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 29, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)