Abstract

The burden of COVID-19 is increasing all over the world. Patients affected with COVID-19 with a previous history of comorbidities, such as respiratory illnesses, are at a higher risk for severe illness, resulting in adverse outcomes. Up-regulation of the immune system by immunomodulators is crucial in the current scenario in India, especially in patients with recurrent respiratory tract infections such as allergic rhinitis (AR) and chronic rhinosinusitis (CRS). Current management options for AR and CRS include allergen avoidance and use of second-generation antihistamines (such as fexofenadine), leukotriene receptor antagonist (montelukast), and intranasal corticosteroids (INCS) aim for symptomatic relief. Antibiotics, such as azithromycin and amoxicillin–clavulanate (AMC), are prescribed for patients with CRS to treat acute bacterial exacerbations of CRS. Pidotimod is a potent allopathic immunomodulator available in India with proven clinical benefits in adult patients with respiratory infections in primary and secondary immune deficiencies. Studies have shown that Pidotimod adjuvant therapy can prevent cytokine cascade activation and potentiate immune responses against viruses. This consensus report summarizes expert opinion and views on the use of Pidotimod in trying times like COVID-19 in patients with mild-to-moderate symptoms of COVID-19 disease and in adult patients with a risk or established history of AR and CRS.

Keywords: COVID-19; SARS-Cov-2; Pidotimod; India; ENT; Chronic Rhinosinusitis; Allergic Rhinitis; Expert Opinion

References

1. Bhattacharya K., et al. “Spectrum of allergens and allergen biology in India”. International Archives of Allergy and Immunology 177 (2018): 219-237.
2. Arun KTM., et al. “To evaluate clinico - microbiological profile in chronic rhinosinusitis: A prospective cohort study in North India”. Journal of Otolaryngology and Rhinology 6 (2020): 084.
3. Sanyaolu A., et al. “Comorbidity and its impact on patients with COVID-19 [published online ahead of print, 2020 Jun 25]”. SN Comprehensive Clinical Medicine (2020): 1-8.
4. May JR and Dolen WK. “Management of allergic rhinitis: A review for the community pharmacist”. Clinical Therapeutics 39 (2017): 2410-2419.
5. Piromchai P., et al. “Chronic rhinosinusitis and emerging treatment options”. International Journal of General Medicine 6 (2013): 453-464.
6. Feleszko W., et al. “Immunoactive preparations and regulatory responses in the respiratory tract: potential for clinical application in chronic inflammatory airway diseases”. Expert Review of Respiratory Medicine 14 (2020): 603-619.
7. Yang M., et al. “Inhaled corticosteroids and risk of upper respiratory tract infection in patients with asthma: a meta-analysis”. Infection 47 (2019): 377-385.
8. Shapiro DJ., et al. “Antibiotic prescribing for adults in ambulatory care in the USA, 2007-09”. Journal of Antimicrobial Chemotherapy 69 (2014): 234-240.
9. Harris AM., et al. “High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention”. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care from the American College of Physicians and the Centers for Disease Control and Prevention”. Annals of Internal Medicine 164 (2016): 425-434.
10. Mahashur A., et al. “Pidotimod: In-depth review of current evidence”. Lung India 36 (2019): 422-433.
11. El-Anwar MW., et al. “ENT manifestation in COVID-19 patients”. Auris Nasus Larynx 47 (2020): 559-564.
12. Diao B., et al. “Reduction and functional exhaustion of T cells in patients with coronavirus disease 2019 (COVID-19)”. Frontiers in Immunology 11 (2020): 827.
13. Bose S., et al. “Infectious chronic rhinosinusitis”. The Journal of Allergy and Clinical Immunology: In Practice 4 (2016): 584-589.
14. Singh AK., et al. “Diabetes in COVID-19: Prevalence, pathophysiology, prognosis and practical considerations”. Diabetes and Metabolic Syndrome 14 (2020): 303-310.
15. Zhang Z., et al. “The effect of diabetes mellitus on chronic rhinosinusitis and sinus surgery outcome”. International Forum of Allergy and Rhinology 4 (2014): 315-320.
16. Talwar Deepak., et al. “A review on the role of Pidotimod in prevention of acute exacerbations of chronic obstructive pulmonary disease”. IP Indian Journal of Immunology and Respiratory Medicine 4 (2019): 15-23.
17. Koatz AM., et al. “Clinical and immunological benefits of OM-85 bacterial lysate in patients with allergic rhinitis, asthma, and COPD and recurrent respiratory infections”. Lung 194 (2016): 687-697.
18. Puggioni F., et al. “Immunostimulants in respiratory diseases: Focus on Pidotimod”. Multidisciplinary Respiratory Medicine 14 (2019): 31.
19. Ucciferri C., et al. “Pidotimod in paucisymptomatic SARS-CoV2 infected patients”. Mediterranean Journal of Hematology and Infectious Diseases 12 (2020): e2020048.
20. Sandhu S., et al. “Clinico therapeutic profile of patients suffering from sinusitis”. Journal of Transmitted Diseases and Immunity 1 (2017): 1.
21. Klimek L., et al. “ARIA guideline 2019: Treatment of allergic rhinitis in the German health system”. Allergologie Select 3 (2019): 22-50.
22. Walekar A., et al. “Assessment of bioequivalence of fexofenadine and montelukast fixed dose combination tablet versus separate formulations of the individual components at the same dose levels”. Indian Journal of Pharmaceutical Sciences 78 (2016): 651-656.
23. Cingi C., et al. “Efficacy of leukotriene antagonists as concomitant therapy in allergic rhinitis”. Laryngoscope 120 (2010): 1718-1723.
24. Tran DH., et al. “Azithromycin, a 15-membered macrolide antibiotics, inhibits influenza A(H1N1) pdm09 virus infection by interfering with virus internalization process”. The Journal of Antibiotics 72 (2019): 759-768.
25. Andreani J., et al. “In vitro testing of combined hydroxychloroquine and azithromycin on SARS-CoV-2 shows synergistic effect”. Microbial Pathogenesis 145 (2020): 104228.
26. Bleyzac N., et al. “Azithromycin for COVID-19: More Than Just an Antimicrobial?” Clinical Drug Investigation 40 (2020): 683-686.
27. Pani A., et al. “Macrolides and viral infections: focus on azithromycin in COVID-19 pathology”. International Journal of Antimicrobial Agents 56 (2020): 106053.
28. Henry DC., et al. “Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis”. Antimicrobial Agents and Chemotherapy 47 (2003): 2770-2774.
29. Gautret P., et al. “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial”. International Journal of Antimicrobial Agents 56 (2020): 105949.
30. Andreani J., et al. “In vitro testing of combined hydroxychloroquine and azithromycin on SARS-CoV-2 shows synergistic effect”. Microbial Pathogenesis 145 (2020): 104228.