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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345653
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

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. Given the lack of data regarding use of HCQ for COVID-19 prevention in healthy participants in midst of pandemic crisis, this study proposes an expedited feasibility study focusing on safety and early efficacy.

Prior to HCQ administration, baseline SARS-CoV-2 and other baseline biomarker testing will be conducted. During the 4-week study period, participants will be monitored for drug related adverse events and assessed for development of COVID. SARS-CoV-2 assay and biomarker testing will be repeated at the end of four-week study. Safety outcomes will be assessed by the number of adverse events (AEs) and their severity; and early efficacy as the number of participants who tested positive at the end of the 4-week period comparing to data collected by occupational Health regarding the total number of high-risk healthcare workers that were tested positive during the same period and historical controls from known high risk infection rates. An exploratory analysis of inflammatory regulation and immunomodulatory markers by HCQ and its effect on possible disease modification based on previously studied pathophysiological mechanism of COVID-19.

The broader aim of this study is to set a precedent to facilitate a large-scale emergent public health intervention. Purpose would be to mitigate, or abort further transmission of COVID-19. Given that COVID-19 transmission has occurred prior to initiation of this study, the rationale for this intervention is based on prior epidemiological evidence. Post-infectious or vaccination-induced immunity in at least 30% of population at-risk has been shown to mitigate or abort propagation of a local epidemics and global pandemic. This would help flatten the curve of the disease progression, until such time that a vaccine may become available. Data from this study will be used to design and implement a population-based phase IIb/III randomized clinical trial.


Condition or disease Intervention/treatment Phase
COVID19 Drug: Hydroxychloroquine Sulfate (HCQ) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility, Safety and Early Efficacy Trial of Hydroxychloroquine as Primary Prevention of Corona Virus Disease 2019 in High Risk Health Care Providers
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : April 8, 2021
Estimated Study Completion Date : April 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study arm
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)
Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.




Primary Outcome Measures :
  1. Recruitment Feasibility [ Time Frame: Study period , up to two months from the day the first participant was screened ]
    To evaluate the feasibility of this protocol including participants' recruitment within the estimated time frame.

  2. Recourse utilization [ Time Frame: Study period , up to two months from the day the first participant was screened ]
    To evaluate the utilization of tests and drug for this study in consideration with the limited availability of both for research purposes.

  3. Safety as reflected on the number and severity of adverse events and serious adverse events [ Time Frame: 28 day post enrollment ]
    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.

  4. Early feasibility as reflected on the number of participants contracting COVID-19 (10% or less) in comparison to the expected 30% as per CDC. [ Time Frame: 28 day post enrollment ]
    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.


Secondary Outcome Measures :
  1. Effect of basic inflammatory regulation [ Time Frame: 28 day post enrollment ]
    To evaluate the effect of basic inflammatory regulation due to interventional drug and its effect on possible disease modification based on understood pathophysiological mechanism of COVID-19. COVID specific inflammatory response including cytokine IL-6 levels would be compared at the start and end of 4 week study with interventional drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 HCP's 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.

Exclusion Criteria:

  • 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.

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): NCT04345653


Locations
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United States, New Jersey
Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, United States, 08820
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Jawad Kirmani, MD Hackensack Meridian Health Corporation
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04345653    
Other Study ID Numbers: Pro2020-0356
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: No
Keywords provided by Hackensack Meridian Health:
covid-19
workers
prevention
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents