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

NCT05458336 | Completed

• 1 other identifier: 991/CE MARCA
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time of negativization

  From date of the first positive swab until the date of to the first negative swab, up to 14 days

Study Arms (2)

Cases

EXPERIMENTAL

Subjects who have been given nasal lavages

Device: Nasal lavages with Tonimer Panthexyl®

Controls

NO INTERVENTION

Subjects who haven't been given nasal lavages

Interventions

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.

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Unit of Otorhinolaryngology of Treviso Hospital

Treviso, 31100, Italy

Location

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Giacomo Spinato, MD

  Universiry of Padova

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 14, 2022
• Study Start: March 8, 2022
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-06

Locations

IT (1)