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

Study Overview
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Brief Summary
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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.

Official Title
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Saline Nasal Irrigations to Eradicate SARS-CoV-2

Conditions
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Symptoms and Signs

Intervention / Treatment
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* Device: Nasal lavages with Tonimer Panthexyl®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases<br>Subjects who have been given nasal lavages | Device: Nasal lavages with Tonimer Panthexyl®<br>* At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to subjectively evaluate symptoms and comorbidities at the moment of diagnosis and of negativization. Subjects performed a daily nasal swab. When the subjects tested negative for the first time, they had to complete the questionnaire once again. Patients were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab.<br>|
| No Intervention: Controls<br>Subjects who haven't been given nasal lavages | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of negativization | Evaluation of differences in negativization time between cases and controls | From date of the first positive swab until the date of to the first negative swab, up to 14 days |