TITLE: High-dose Hydroxychloroquine for Mild COVID-19: One Center’s
Clinical Experience and Investigational Challenges
AUTHORS: Iazsmin Bauer Ventura, MD MSc; Brian W. Labadie, MD; Patrick
Onkka, MD; Pankti Reid, MD; Moira McNulty, MD; Cuoghi Edens, MD; David
G. Beiser, MD MS; Mark Ratain, MD; Reem Jan, MBBS BSc
AFFILIATIONS: University of Chicago, Department of Medicine, Section of
Rheumatology (IBV, PR, CE, RJ); University of Chicago, Department of
Medicine (BL); University of Chicago, Department of Medicine, Section of
Infectious Diseases & Global Health (MM); University of Chicago,
Department of Pediatrics, Section of Pediatric Rheumatology (CE);
University of Chicago, Department of Emergency Medicine (DGB);
University of Chicago, Department of Medicine, Section of Hematology and
Oncology (MR); Northwestern Medical Group (PO)
CORRESPONDING AUTHOR:
Iazsmin Bauer Ventura
5841 South Maryland Avenue, N005D
Chicago, IL 60637
email: Iazsmin.ventura@uchospitals.edu
PRINCIPAL INVESTIGATOR STATEMENT: The authors confirm that the Principal
Investigator for this paper is Dr. Reem Jan and that she has direct
clinical responsibility for the patients included in this study.
AUTHORSHIP STATEMENT: All persons who meet authorship criteria are
listed as authors, and all authors certify that they have participated
sufficiently in the work to take public responsibility for the concept,
design analysis, writing, or revision of the manuscript. Furthermore,
each author certifies that this material or similar material has not
been and will not be submitted to or published in any other publication
before its appearance in the British Journal of Clinical
Pharmacology.
CONFLICT OF INTEREST DISCLOSURE: The authors whose names are listed
above certify that they have NO affiliations with or involvement in any
organizations or entity with any financial or non-financial interest in
the subject matter or materials discussed in this manuscript.
ETHICS APPROVAL STATEMENT/ PERSONAL COSENT STATEMENT: This study was
approved by the University of Chicago Institutional Review of Boards and
all patients included in this study signed a consent form.
DATA AVAILABILITY STATEMENT: The data that supports the findings of this
study are available on request from the corresponding author (IBV). The
data are not publicly available due to their containing information that
could compromise the privacy of research participants.
FUNDING STATEMENT: This study did not receive any funding outside the
University of Chicago.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04351620
KEY WORDS: hydroxychloroquine, SARS-CoV-2, COVID-19, clinical trial,
tolerability, review.
WORD COUNT: 3,351
TABLE COUNT: 1 table
FIGURE COUNT: 1 figure
ABSTRACT:
Aims: The recently described SARS-CoV-2 has led to a pandemia
which has severe consequences for the global community.
Hydroxychloroquine has been repurposed for the treatment of COVID-19 but
conflicting information on its efficacy and safety has since emerged.
Our group designed a trial on the use of high-dose hydroxychloroquine in
a high-risk ambulatory population with mild COVID-19 (NCT04351620) and
summarizes herein the clinical data of hydroxychloroquine in COVID-19.
Methods: Single-arm and single-center study evaluating the
tolerability of high-dose hydroxychloroquine, 600 mg twice daily for 5
days, in patients with mild COVID-19 and risk factors for clinical
decompensation and hospitalization. Secondary objectives included
maintenance of ambulatory status, defervescence, and symptom relief.
Results: Over a six-week period, 59 patients met eligibility
criteria out of 314 contacted (18.7%). Out of these 59 potentially
eligible patients, 44 (74.5%) patients declined to be screened further
due to concerns about its risks and unproven efficacy, referencing media
accounts and politization of the medication. Out of the 9 patients
consented, 2 did not complete the therapy plan, 1 due to headaches, 1
did not follow up. Two of the 7 patients who completed the study
continued to have fevers, one was admitted for pneumonia. Study was
terminated early due to recruitment difficulties.
Conclusions: The trial met pre-defined primary outcome of
tolerability, but sample size was too small to allow further
interpretation. The political climate and media coverage might have
negatively impacted patient recruitment, which has ultimately led to its
early interruption.
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