Olfactory Disfunction and Co-ultraPEALut
Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut
Sponsor: Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy
A PHASE4 clinical study on Anosmia and Covid19, this trial is completed. The trial is conducted by Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy and has accumulated 6 data snapshots since 2020. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)Patients ages 18 to 70 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 (T0). One group received daily olfactory training, 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), or 1 dose of PEA-LUT only or aTwo Dose of PEA-LUT.
Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days
Patients ages 18 to 70 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 (T0). One group received daily olfactory training, 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), or 1 dose of PEA-LUT only or aTwo Dose of PEA-LUT.
Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Dec 2022 — Jul 2024 [monthly]
Completed PHASE4
-
Nov 2021 — Dec 2022 [monthly]
Completed PHASE4
Status: Not Yet Recruiting → Completed
-
Sep 2021 — Nov 2021 [monthly]
Not Yet Recruiting PHASE4
▶ Show 1 earlier version
-
May 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE4
First recorded
Nov 2020
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Azienda Ospedaliero Universitaria di Sassari
- Azienda Ospedaliero-Universitaria Careggi
- Federico II University
- Humanitas Hospital, Italy
- Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino
- Ospedale Bufalini di Cesena, Italy
- Ospedale Universitario di Genova, Italy
- Policlinico Universitario, Catania
- San Giovanni Addolorata Hospital
- University Of Perugia
For direct contact, visit the study record on ClinicalTrials.gov .