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

Symptoms and Signs Clinical Trial

Official title:

Saline Nasal Irrigations to Eradicate SARS-CoV-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458336
• Other study ID #: 991/CE MARCA
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: April 14, 2022

Study information

• Verified date: June 2022
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Symptoms and Signs

Intervention

Device:
• Nasal lavages with Tonimer Panthexyl®
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.

Locations

Country	Name	City	State
Italy	Unit of Otorhinolaryngology of Treviso Hospital	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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