Saline Nasal Irrigations to Eradicate SARS-CoV-2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 107
- Locations
- 2
- Primary Endpoint
- Symptoms' course
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Time of negativization(From date of the first positive swab until the date of to the first negative swab, up to 14 days)