Washing COVID-19 Away With a Hypertonic Seawater Nasal Irrigation Solution

November 2, 2023 updated by: Ioannis Pantazopoulos, Larissa University Hospital

Washing COVID-19 Away With a Hypertonic Seawater Nasal Irrigation Solution Containing Algal and Herbal Natural Ingredients

Nasal irrigations are thought to reduce the amount of virus from the nasal cavity. The aim of the present study is to evaluate the effect of a hypertonic seawater solution containing algal and herbal natural ingredients (Sinomarin®) on the nasopharyngeal viral load in hospitalized patients with severe COVID-19 pneumonia. The investigators will conducted a prospective, randomized, controlled trial. Patients will be allocated in two groups, the hypertonic seawater group receiving nasal irrigations with a hypertonic seawater solution (Sinomarin®) every 4 hours during a 16-hour interval per day, for two consecutive days, and the control group (no nasal irrigations). Forty-eight hours after the baseline nasopharyngeal swab (and 8 hours after the last wash in the hypertonic seawater group), a second nasopharyngeal swab will be collected for the semiquantitative estimation of the SARS-CoV-2 viral load as determined by cycle threshold (Ct) values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will perform a prospective, randomized, controlled study in 56 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 hypertonic seawater group (will receive a hypertonic (2.3% NaCl) seawater solution containing brown algae (Undaria pinnatifida) and blue-green algae (Spirulina platensis) as well as essential oils of Eucalyptus globulus and Mentha spicata, and Thymus vulgaris extract (Sinomarin® Plus Algae Cold & Flu Relief, Gerolymatos International SA, Krioneri, Greece)) and the control group (no treatment). Sinomarin® is a medical device that utilizes continuous flow diffusion. The solution continues to flow as long as the nozzle is pressed, providing efficient cleansing.

At admission, a baseline nasopharyngeal swab will be collected from all patients and placed in a sterile bottle containing virus transport medium (10 ml tube with 3 ml medium, Biobase, Biodustry, Shandong, China) for SARS-CoV-2 nucleic acid detection (zero hour). Patients in the hypertonic seawater group will be given a review on the proper technique for nasal irrigation. Specifically, they will be instructed to blow their nose before irrigation, gently bend their neck forward, tilt their head to one side, and insert the nozzle into the nostril in line with the nasal septum. They will be advised to press firmly on the nozzle to squirt the solution into the nostril and then repeat the process on the other nostril. The patients will also be instructed to spit out any solution coming into their mouth and then return to an upright position to allow the solution to work for a few seconds before blowing their nose gently. After each use, they will be advised to remove the nozzle from the bottle, wash it thoroughly with warm water, and wipe it dry. Thereafter, patients will be given one bottle of 200 ml Sinomarin® and will be instructed to perform nasal irrigation to each nostril every 4 hours for a 16-hour period per day, for two consecutive days.

Forty-eight hours after the baseline nasopharyngeal swab and 8 hours after the last nasal wash, a second nasopharyngeal swab will be collected for viral load measurement. All nasopharyngeal swabs will be collected by a physician blinded to group allocation and will be collected from the same nostril for each patient.

Demographic data including age, sex, nationality, body mass index, smoking status, and date of admission will be collected at baseline. Data on comorbidities, Charlson comorbidity index, disease related symptoms, vaccination status, presenting day of illness since symptom onset, oxygenation status (PaO2/FiO2), and medication administered will also be recorded. Furthermore, outcome and potential adverse effects related to use of hypertonic seawater solution containing algal and herbal natural ingredients will be recorded. All patients will be followed until hospital discharge, 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

Interventional

Enrollment (Actual)

56

Phase

  • 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, 41500
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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
Intervention / Treatment
Experimental: Hypertonic seawater group
Patients that will receive nasal irrigations with hypertonic (2.3% NaCl) seawater solution containing brown algae (Undaria pinnatifida) and blue-green algae (Spirulina platensis) as well as essential oils of Eucalyptus globulus and Mentha spicata, and Thymus vulgaris extract (Sinomarin® Plus Algae Cold & Flu Relief, Gerolymatos International SA, Krioneri, Greece)
Other: Hypertonic seawater solution
Nasal irrigations with hypertonic seawater solution
Other Names:
  • Sinomarin
No Intervention: control group
Patients that will not perform nasal irrigations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV2 viral load
Time Frame: 48 hours
SARS-CoV2 viral load in nasopharyngeal swab in hospitalized patients with COVID-19 pneumonia
48 hours

Secondary Outcome Measures

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

Larissa University Hospital

Investigators

  • Study Director: Ioannis Pantazopoulos, MD, University Hospital Of Larissa

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)

June 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13149

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

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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