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

NCT05458336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2022-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Giacomo Spinato, MD · Universiry of Padova

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-04-14
Completion
2022-04-14

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05458336 on ClinicalTrials.gov