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Clinical Trial Summary

Olfactory dysfunction is common among patients with Corona-Virus-Infection-Disease (COVID)-19, and up to 30% of patients may report persistent disorders of smell or taste as a long-term sequelae. This randomized-controlled study has addressed to compare the efficacy of neuro-protective and anti-inflammatory agents palmitoylethanolamide (PEA) and Luteolin(Treatment) with control (olfactory training) in a cohort of patients who present persistent smell disorders after resolution from Covid-19 and negative swab for 4 months at least.

Clinical Trial Description

Patients ages 18 to 90 years with confirmed history of COVID-19 (positive nasopharyngeal swab for SARS-CoV-2) and subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative COVID-19 nasopharyngeal swab are eligible. All patients will undergo nasal endoscopic examination to look for presence of polyps, masses, anatomic blockage, or other pathology which presence will require exclusion from the study. Patients then will be evaluated at the baseline with Sniffin' Sticks (Burghardt®, Wedel, Germany) prior to initiating olfactory training and/or supplement treatment/nasal spray (T0). Three groups received weekly olfactory training, and patients in the supplement group additionally received a daily oral tablet that contained PEA 700 mg and Luteolin 70 mg (Glialia ®, Epitech pharmaceutical, Milano, Italy), while the one in spray group -nasal cortisone. Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04853836
Study type Interventional
Source University Of Perugia
Status Not yet recruiting
Phase Phase 4
Start date April 25, 2021
Completion date December 31, 2021

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