Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers

NCT04345653 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro2020-0356
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study proposes to conduct an open-label Phase II trial to evaluate the feasibility, safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50 years track record of safety of HCQ for treatment and prevention of various disease states. Early data on use of HCQ for COVID treatment suggests anti-viral activity and immunomodulatory properties for reducing inflammation associated with COVID-19.

Conditions

Covid19

Keywords

covid19; workers; prevention

Outcome Measures

Primary Outcomes (4)

• Recruitment Feasibility

  To evaluate the feasibility of this protocol including participants' recruitment within the estimated time frame, i.e. understand the ability of the team to identify eligible participants, enroll them, retain them and follow them up until study completion.

  Study period, up to two months from the day the first participant was screened

• Resource Utilization

  To evaluate the utilization of tests and drug for this study in consideration with the limited availability of both for research purposes as reflected on the number of participants that got tested and received at least one dose of the drug.

  Study period, up to two months from the day the first participant was screened

• Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse Events

  To Determine the Safety profile for a previously well studied drug in this select group of HCP. Incidence of well described side effects would be studied over the course of the study and will be compared with the side effects and their prevalence as described in the Pharmacy manual for HCQ.

  28 day post enrollment

• Early Feasibility as Reflected on the Number of Participants Contracting COVID-19 (10% or Less) in Comparison to the Expected 30% as Per CDC.

  To evaluate the early efficacy of HCQ in high-risk, healthy volunteers in the prevention of acquiring COVID-19 while continuing to follow standard precautions that meet or exceed Centers of Disease Control (CDC) guidelines.

  28 day post enrollment

Study Arms (1)

Study arm - Hydroxychloroquine Sulfate (HCQ)

EXPERIMENTAL

HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth

Drug: Hydroxychloroquine Sulfate (HCQ)

Interventions

Hydroxychloroquine Sulfate (HCQ) DRUG

Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.

Study arm - Hydroxychloroquine Sulfate (HCQ)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers ages 18 to 99 years,
• Able to sign own informed consent form,
• Considered high-risk healthcare care providers in a hospital setting with active exposure to COVID-19 infection.
• High-risk healthcare providers are defined as those actively working during the study duration in the Emergency Department and in the Intensive Care Setting, for the purpose of this study.

You may not qualify if:

• Inability to tolerate an oral medication or known allergy to chloroquine or hydroxychloroquine
• Pregnancy or breast-feeding
• Immunocompromised status, hepatic failure, electrolytic imbalance
• Creatinine clearance (CCL) \<30 mL/min
• Prolonged QT interval (QTc \> 450ms for males and QTc \> 470 for females)
• Confirmed COVID-19 infection on baseline testing
• Has another known contraindication to treatment with the study drug, including retinopathy.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Meridian Health - JFK Medical Center

Edison, New Jersey, 08820, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; 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: Dr. Jawad Kirmani
• Organization: JFK University Medical Center - Hackensack Meridian Health

jawad.kirmani@hmhn.org

7327745805

Study Officials

• Jawad Kirmani, MD

  Hackensack Meridian Health Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: April 14, 2020
• Primary Completion: June 5, 2020
• Study Completion: May 10, 2021
• Last Updated: May 12, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)