Inhaled hydroxychloroquine to improve efficacy and reduce harm in the treatment of COVID-19
Kavanagh et al.,
Inhaled hydroxychloroquine to improve efficacy and reduce harm in the treatment of COVID-19,
Med. Hypotheses, doi:10.1016/j.mehy.2020.110110
Proposal to use an inhaled formulation of HCQ which has passed safety studies in clinical trials for the treatment of asthma. Authors advocate for early treatment or prophylaxis of COVID-19, using HCQ as an inhaled aerosol, to deliver the drug directly to the lungs at a lower dose than that required for oral systemic delivery.
Kavanagh et al., 15 Jul 2020, peer-reviewed, 9 authors.
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Medical Hypotheses 143 (2020) 110110
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Letter to Editors
Inhaled hydroxychloroquine to improve efficacy and reduce harm in the treatment of COVID-19
T
ABSTRACT
Current formulations and dose regimens of hydroxychloroquine (HCQ) put patients at risk of harm. An analysis of clinical trials registered on ClinicalTrials.gov
revealed that this may continue as many studies combine HCQ with agents that prolong the QT interval. Further, almost all of the trials registered do not consider
dosage adjustment in the elderly, a patient population most likely to require HCQ treatment. Here we describe an inhaled formulation of HCQ which has passed safety
studies in clinical trials for the treatment of asthma and discuss how this approach may reduce side-effects and improve efficacy. As this simple formulation
progressed to phase II studies, safety data can be used to immediately enable phase II trials in COVID-19.
The COVID-19 (SARS-CoV-2) pandemic has had devastating health
consequences worldwide [1], and life has been brought to a standstill as
the world awaits a vaccine. Meanwhile, many patients continue to fall
critically ill and, in the absence of a vaccine, antivirals and other
treatments to alleviate the effects of the disease are urgently sought.
In recent months, since the outbreak of COVID-19, a large number of
clinical trials have been registered on ClinicalTrials.gov with the aim of
repurposing medicines to reduce the severity of the disease [2]. Chloroquine
and hydroxychloroquine (HCQ) were two of the earliest drugs to receive
attention as possible repurposable treatment options for COVID-19 [3].
Indeed, a number of studies investigated their anti-SARS-CoV activity as
early as 2003 [4–6]. However, the potential efficacy of HCQ must be balanced against its side-effects, particularly those associated with QT elongation, which is exacerbated by age, comorbidities and administration with
other agents (such as azithromycin) that prolong the QT interval [7]. A
recent analysis of NHS (UK) electronic health records revealed that the most
striking risk factors for COVID-19 death were age and male gender [8], and
those same risk factors have been identified previously in the context of
drug induced QT elongation [9,10]. Concerns associated with severe side
effects are such that the FDA and EMA now formally recommend against
taking HCQ for COVID-19 infection unless it is being prescribed in the
hospital or as part of a clinical trial [11,12].
Our analysis of the 185 trials registered with ClinicalTrials.gov (13th
May 2020) using the search terms “COVID-19 and..
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
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