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

NCT ID: NCT05458336

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2022-04-14

Brief 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.

Conditions

Symptoms and Signs

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cases

Subjects who have been given nasal lavages

Group Type: EXPERIMENTAL

Nasal lavages with Tonimer Panthexyl®

Intervention Type: 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.

Controls

Subjects who haven't been given nasal lavages

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giacomo Spinato, MD

Role: STUDY_CHAIR

Universiry of Padova

Locations

Unit of Otorhinolaryngology of Treviso Hospital

Treviso, , Italy

Countries

Italy

Other Identifiers

991/CE MARCA

Identifier Type: -

Identifier Source: org_study_id