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Completed

NCT Number: NCT05458336

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

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.

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Key information

Conditions

Symptoms and Signs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Otorhinolaryngology of Treviso Hospital

Treviso, 31100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal lavages with Tonimer Panthexyl®

Device

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.

Primary outcomes

  1. Symptoms' course

    Time frame: 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 outcomes

  1. Time of negativization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Saline Nasal Irrigations to Eradicate SARS-CoV-2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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