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

Saline Nasal Irrigations to Eradicate 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.

Study Overview

• Status: Completed
• Conditions: Symptoms and Signs
• Intervention / Treatment: Device: Nasal lavages with Tonimer Panthexyl®

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Treviso, Italy, 31100
    • Unit of Otorhinolaryngology of Treviso Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cases; Subjects who have been given nasal lavages	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.
NO_INTERVENTION: Controls; Subjects who haven't been given nasal lavages

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Study Chair: Giacomo Spinato, MD, Universiry of Padova

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2022
• Primary Completion (ACTUAL): April 14, 2022
• Study Completion (ACTUAL): April 14, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (ACTUAL): July 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 991/CE MARCA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No