A Randomized Controlled Clinical Trial on the Use of Saline Nasal Irrigations to Eradicate Localized Nasal Infection by SARS-CoV-2

Not Applicable

Completed

• Conditions: Symptoms and Signs
• Interventions: Device: Nasal lavages with Tonimer Panthexyl®

• Registration Number: NCT05458336
• Lead Sponsor: University of Padova

Brief Summary

Consecutive adult (\>18 years old) subjects who tested positive for SARS-CoV-2 with nasopharyngeal swab at the local COVID-19 Prevention Centre were included.

Patients were divided into two groups: cases (who performed nasal lavages) and controls (who did not perform lavages), with similar confounding factors (age, comorbidities, vaccination status).

At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to evaluate their symptoms at the moment of diagnosis and of negativization.

Subjects were asked to perform, at a daily time of their choice, a nasal swab provided at the moment of enrolment. When the subjects tested negative for the first time, they had to complete the questionnaire once again.

The study was divided into two phases. In the first phase cases were recruited and were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab. In the second phase controls were recruited and were asked to perform only daily nasal swabs.

Symptoms course and time of negativization were analyzed. Statistic comparisons were made using Kaplan-Meier test. P values \<0,05 were considered to be statistically significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Status Verified: 2022-06
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• age >18 years
• starting participation to the study within the first 48 hours since diagnosis
• ability in self-swabbing
• ability in self-administration of nasal lavages

Exclusion Criteria

• age <18 years
• refusal of participation
• starting participation to the study after the first 48 hours since diagnosis
• no ability in self-swabbing
• no ability in self-administration of nasal lavages

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cases	Nasal lavages with Tonimer Panthexyl®	Subjects who have been given nasal lavages

Primary Outcome Measures

Name	Time	Method
Symptoms' course	From date of the first positive swab until the date of to the first negative swab, up to 14 days	Evaluation of differences in disease's course between cases and controls by filling an ad hoc questionnaire about symptoms

Secondary Outcome Measures

Name	Time	Method
Time of negativization	From date of the first positive swab until the date of to the first negative swab, up to 14 days	Evaluation of differences in negativization time between cases and controls

Trial Locations

Locations (1)

Unit of Otorhinolaryngology of Treviso Hospital; 🇮🇹 Treviso, Italy