High-dose Hydroxychloroquine for Mild COVID-19: One Center’s Clinical
Experience and Investigational Challenges
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.