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Levocetirizine and montelukast in the COVID-19 treatment paradigm

May et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.108412
Feb 2022  
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29th treatment shown to reduce risk in November 2021, now with p = 0.0041 from 9 studies.
Lower risk for hospitalization and cases.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Retrospective 53 patients reporting a potential benefit with levocetirizine and montelukast treatment for COVID-19. 51 of 53 patients were considered clinically cured on the combination therapy, with symptom resolution typically within 7 days. The study included patients with significant comorbidities. There were no deaths or reported treatment-related safety issues.
May et al., 28 Feb 2022, retrospective, peer-reviewed, 2 authors, study period March 2020 - November 2020. Contact: bcmay@irrinc.net, kathleen_gallivan@meei.harvard.edu.
This PaperMontelukastAll
Levocetirizine and montelukast in the COVID-19 treatment paradigm
Bruce Chandler May, Kathleen Holly Gallivan
International Immunopharmacology, doi:10.1016/j.intimp.2021.108412
Levocetirizine, a third-generation antihistamine, and montelukast, a leukotriene receptor antagonist, exhibit remarkable synergistic anti-inflammatory activity across a spectrum of signaling proteins, cell adhesion molecules, and leukocytes. By targeting cellular protein activity, they are uniquely positioned to treat the symptoms of COVID-19. Clinical data to date with an associated six-month follow-up, suggests the combination therapy may prevent the progression of the disease from mild to moderate to severe, as well as prevent/treat many of the aspects of 'Long COVID,' thereby cost effectively reducing both morbidity and mortality. To investigate patient outcomes, 53 consecutive COVID-19 test (+) cases (ages 3-90) from a well-established, single-center practice in Boston, Massachusetts, between March -November 2020, were treated with levocetirizine and montelukast in addition to then existing protocols [2] . The data set was retrospectively reviewed. Thirty-four cases were considered mild (64%), 17 moderate (32%), and 2 (4%) severe. Several patients presented with significant comorbidities (obesity: n = 22, 41%; diabetes: n = 10, 19%; hypertension: n = 24, 45%). Among the cohort there were no exclusions, no intubations, and no deaths. The pilot study in Massachusetts encompassed the first COVID-19 wave which peaked on April 23, 2020 as well as the ascending portion of the second wave in the fall. During this period the average weekly COVID-19 case mortality rate (confirmed deaths/confirmed cases) varied considerably between 1 and 7.5% [37] . FDA has approved a multicenter, randomized, placebo-controlled, Phase 2 clinical trial design, replete with electronic diaries and laboratory metrics to explore scientific questions not addressed herein.
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: B. Chandler May, MD, JD, MS, FCLM is a practicing physician and CEO of Inflammatory Response Research, Inc. (IRR, Inc.) a drug development company focused on the combination of levocetirizine and montelukast for the treatment of inflammatory disorders. The current retrospective study utilized commercially available levocetirizine and montelukast from sources unrelated to IRR, Inc; independently prescribed by Kathleen Holly Gallivan, MD, MPH, FACS, FAAOA. Dr. Gallivan has no financial interests to report.
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