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

University of Padova

Status: Completed

Conditions: Symptoms and Signs

Treatments: Device: Nasal lavages with Tonimer Panthexyl®

Study type: Interventional

Funder types: Other

Identifiers

NCT05458336

991/CE MARCA

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Cases

Experimental group

Description:

Subjects who have been given nasal lavages

Treatment:

Device: Nasal lavages with Tonimer Panthexyl®

Controls

No Intervention group

Description:

Subjects who haven't been given nasal lavages