Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load

August 30, 2022 updated by: Ioannis Pantazopoulos, Larissa University Hospital

Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • University Hospital of Larissa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal saline group
Patients that will receive normal saline 0.9% solution for nasopharyngeal wash
Other: Normal saline
Nasopharyngeal washes with NaCl 0.9%
Other Names:
  • NaCl 0.9%
No Intervention: control group
Patients that will not perform nasopharyngeal washes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SARS-CoV2 viral load
Time Frame: 24 hours
SARS-CoV2 viral load in nasopharyngeal swab in hospitalized patients with COVID-19 pneumonia
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for escalation to HFNC / NIV, ICU admission
Time Frame: From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months
Number of participants with need for escalation to high flow nasal oxygen or non-invasive ventilation or ICU admission in patients with COVID-19 pneumonia.
From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Larissa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected individual participant data (IPD)

IPD Sharing Time Frame

For one year after the end of the study

IPD Sharing Access Criteria

Contact study director by e-mail

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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