Clinical trial NCT05525832: Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load
Official title: Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: Nasopharyngeal wash
Normal saline
SARS-CoV2
Viral load
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Pilot Controlled Trial
Primary purpose: OTHER

Brief summary: Although great progress has been made over the past 2 years in the scientific understanding of the biology, epidemiology, and pathogenesis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), case morbidity and fatality rates remain a great concern and continue to challenge the healthcare resources worldwide as novel variants emerge. There is therefore an urgent need for affordable and readily available strategies to reduce viral transmission. Previous studies in non coronavirus disease 2019 (COVID-19) patients have demonstrated that administration of low-salt (isotonic but 0.0375% Na) and isotonic saline (0.9% Na) solutions has been associated with an immediate, significant reduction in the microbial antigens and a related decline of microbial burden. The primary aim of the present study is to determine the effect of nasal washes with normal saline 0.9% on nasopharyngeal viral load in hospitalized patients with COVID-19 pneumonia. The secondary aim is to examine if this effect influences escalation to high flow nasal oxygen or non-invasive ventilation and admission to ICU in patients with COVID-19 pneumonia.

Detailed description: Investigators will perform a prospective, randomized, pilot, controlled study in 50 patients with confirmed COVID-19 pneumonia. All patients will be treated with the standard protocol of care for COVID-19 at the Department of Infectious Diseases and will be randomized into one of two groups with the method of sequentially numbered, opaque, sealed envelopes, the normal saline group (will receive normal saline 0.9% solution for nasopharyngeal wash) and the control group (no treatment). In all patients, an initial baseline nasopharyngeal swab will be obtained at admission and will be placed in a sterile bottle of virus transport medium for SARS-CoV2 nucleic acid detection (day 1). Then, an educational review of nasopharyngeal wash technique will be performed. Patients from the normal saline group will be provided with eight 10 mL sterile bottles of sodium chloride 0.9% (NaCl 0.9%) solution and will be advised to perform nasopharyngeal wash with 10 ml of solution to each nostril, every 4 hours for a 16-hour period. Twenty-four hours after the baseline nasopharyngeal swab, and 8 hours after the last nasopharyngeal wash, a second nasopharyngeal swab will be collected for measurement of the viral load (day 2). All nasopharyngeal swabs will be collected by a physician blinded to group allocation and will be collected from the same nostril for each patient. Each sample will be tested at most up to 12 hours following collection. Patients demographic and clinical information will be recorded at admission \[need for escalation to high flow nasal cannula (HFNC) or non invasive ventilation (NIV). Disease-related symptoms and potential adverse effects related to use of normal saline will also be monitored. All patients will be followed until hospital discharge, intensive care unit (ICU) admission or death. Those that will be discharged will be reexamined 14 days after hospital discharge for real-time polymerase chain reaction (RT-PCR). Manual chart review will be used to gather details of the laboratory studies, course, and outcomes.

Eligibility criteria: Inclusion Criteria:

* adult patients hospitalized primarily for COVID-19 pneumonia
* confirmed SARS-CoV2 infection diagnosed through RT-PCR test of nasopharyngeal samples

Exclusion Criteria:

* patients with confirmed SARS-CoV2 infection who were not primarily admitted for COVID-19 pneumonia
* patients with use of intranasal sprays for at least two weeks prior to study enrollment
* sinonasal surgery within 3 months prior to study enrollment
* patients with sinusitis
* inability to perform nasopharyngeal wash
* participation in other trials

Primary outcomes:
measure: SARS-CoV2 viral load
timeFrame: 24 hours
Secondary outcomes:
measure: Need for escalation to HFNC / NIV, ICU admission
timeFrame: From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: University Hospital of Larissa
name: Ioannis Pantazopoulos, MD
role: STUDY_DIRECTOR
References:
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