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

NCT05729204 | Completed DMC

• 1 other identifier: 13149
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV2 Infection

Keywords

Nasal irrigation; Hypertonic seawater solution; SARS-CoV2; Viral load

Outcome Measures

Primary Outcomes (1)

• SARS-CoV2 viral load

  SARS-CoV2 viral load in nasopharyngeal swab in hospitalized patients with COVID-19 pneumonia

  48 hours

Secondary Outcomes (1)

• Need for escalation to HFNC / NIV, ICU admission

  From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months

Study Arms (2)

Hypertonic seawater group

EXPERIMENTAL

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

control group

NO INTERVENTION

Patients that will not perform nasal irrigations

Interventions

Hypertonic seawater solution OTHER

Nasal irrigations with hypertonic seawater solution

Also known as: Sinomarin

Hypertonic seawater group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41500, Greece

Location

Related Publications (8)

• Pantazopoulos I, Chalkias A, Mavrovounis G, Dimeas I, Sinis S, Miziou A, Rouka E, Poulas K, Gourgoulianis K. Nasopharyngeal Wash with Normal Saline Decreases SARS-CoV-2 Viral Load: A Randomized Pilot Controlled Trial. Can Respir J. 2022 Sep 27;2022:8794127. doi: 10.1155/2022/8794127. eCollection 2022.

  PMID: 36247079 BACKGROUND

• Kanjanawasee D, Seresirikachorn K, Chitsuthipakorn W, Snidvongs K. Hypertonic Saline Versus Isotonic Saline Nasal Irrigation: Systematic Review and Meta-analysis. Am J Rhinol Allergy. 2018 Jul;32(4):269-279. doi: 10.1177/1945892418773566. Epub 2018 May 18.

  PMID: 29774747 BACKGROUND

• Kwon PS, Oh H, Kwon SJ, Jin W, Zhang F, Fraser K, Hong JJ, Linhardt RJ, Dordick JS. Sulfated polysaccharides effectively inhibit SARS-CoV-2 in vitro. Cell Discov. 2020 Jul 24;6(1):50. doi: 10.1038/s41421-020-00192-8. eCollection 2020. No abstract available.

  PMID: 32714563 BACKGROUND

• Pradhan B, Nayak R, Patra S, Bhuyan PP, Behera PK, Mandal AK, Behera C, Ki JS, Adhikary SP, MubarakAli D, Jena M. A state-of-the-art review on fucoidan as an antiviral agent to combat viral infections. Carbohydr Polym. 2022 Sep 1;291:119551. doi: 10.1016/j.carbpol.2022.119551. Epub 2022 May 2.

  PMID: 35698330 BACKGROUND

• Huijghebaert S, Hoste L, Vanham G. Essentials in saline pharmacology for nasal or respiratory hygiene in times of COVID-19. Eur J Clin Pharmacol. 2021 Sep;77(9):1275-1293. doi: 10.1007/s00228-021-03102-3. Epub 2021 Mar 27.

  PMID: 33772626 BACKGROUND

• Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.

  PMID: 30705369 BACKGROUND

• Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.

  PMID: 18209140 BACKGROUND

• Gangadi M, Georgiou S, Moschotzopoulou E, Antronikou T, Kainis E, Alevizopoulos K. Efficacy and safety of a hypertonic seawater nasal irrigation solution containing algal and herbal natural ingredients in patients with COVID-19. Eur Rev Med Pharmacol Sci. 2022 Dec;26(2 Suppl):112-123. doi: 10.26355/eurrev_202212_30495.

  PMID: 36524919 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ioannis Pantazopoulos, MD

  University Hospital of Larissa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 15, 2023
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: For one year after the end of the study
• Access Criteria: Contact study director by e-mail

Locations

GR (1)