Seawater Nasal Wash to Relieve COVID-19 Nasal Symptoms and Reduce SARS-CoV-2 Viral Load. (SeaCare)

June 28, 2023 updated by: Laboratoire de la Mer
Prospective, randomized, controlled, multicenter, parallel clinical trial to assess the efficacy of seawater nasal wash to relieve COVID-19 and URTIs nasal symptoms and reduce intranasal viral load in subjects with mild to moderate COVID-19 disease and URTIs.

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

SARS-CoV-2 coronavirus enters into the human body mainly through the angiotensin converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS2) nasal epithelial cells. Like many other airborne viral diseases, penetration into the upper respiratory tract (URT) is the first step of the infection. Once SARS-CoV-2 enters the host via the respiratory tract, airway and alveolar epithelial cells, vascular endothelial cells and alveolar macrophages are among the first targets of viral entry. Several studies have reported that the viral loads in the upper respiratory tract (URT) peak at the time of, or early after, onset of symptoms. Higher virus load in upper respiratory tract (URT) also induces a higher overall SARS-CoV-2 household secondary attack rate.

Nasal saline irrigations are frequently prescribed for both prevention and treatment of upper respiratory tract infections (URTIs). Nasal wash provides mechanical cleansing of mucus, crust, cell debris and various air contaminants including pathogens (virus and bacteria). It enhances mucociliary clearance and reduces the mucus contact time of airborne elements. The effectiveness of nasal lavage has been shown to reduce the duration of infectious episodes and relieve symptoms of upper respiratory tract infections (URTIs) caused by various respiratory viruses including coronaviruses. Preliminary data showed that daily nasal wash can significantly reduce symptom duration in subjects with mild and moderate forms of COVID-19.

The sponsor hypothesized that the daily use of seawater nasal wash in subjects with mild to moderate forms of COVID-19 or URTIs:

  • Would relieve nasal symptoms caused by SARS-CoV-2 and URTIs virus, including nasal obstruction and rhinorrhea.
  • Would reduce the intranasal viral load by mechanical evacuation of nasal secretions containing the viruses, and by reducing the contact time between the viruses and the nasal mucosa.

The main objective of this study is to evaluate the effectiveness of Physiomer®, an undiluted isotonic seawater nasal spray, on reducing the duration of nasal symptoms (nasal obstruction or rhinorrhea) in subjects with mild to moderate COVID-19 and URTIs.

The study will take place in France among adults subjects who developed nasal obstruction and rhinorrhea no more than 48 hours before study inclusion. Subjects will be randomized into one of two study groups: control group or nasal wash group. Subjects in the nasal wash group will be asked to perform daily nasal wash for a 3 weeks period with Physiomer®, a 100% seawater isotonic nasal spray. Subjects in both groups will complete daily online questionnaires for a 3 weeks period. In order to follow the evolution of intra-nasal viral load, 4 naso-pharyngeal swabs will be collected at home by a nurse.

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.
370

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Cergy, France, 95000
        • Le Carreau

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult subjects (≥ 18 years) with self-reported nasal obstruction and/or rhinorrhea ≤48 hours due to COVID-19 or URTIs
  • Willing to have regular nasopharyngeal swabs as per protocol
  • Subjects agreeing to follow the study requirements during the whole study period
  • Subject affiliated to social security
  • Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself

Exclusion Criteria:

  • Age over 65 years
  • Subjects requiring hospitalization
  • Subjects with severe COVID-19 symptoms
  • Inability or unwillingness to perform saline irrigations
  • subjects who have performed nasal wash in the previous week including the day of inclusion
  • Requirement to take regular medications administered by nasal route (topical treatment such as corticosteroids, antihistaminics, vasoconstrictors, inhalation)
  • Subjects intending to undergo nasal surgery during the study period or who underwent nasal surgery in the 3 previous months.
  • Pregnancy or breastfeeding
  • Cardiovascular pathologies: history of stroke, history of coronary artery disease, history of cardiac surgery, NYHA stage III or IV heart failure;
  • Asthma (requiring treatment)
  • Chronic pulmonary / respiratory pathology (cystic fibrosis, obstructive pulmonary disease (COPD), pulmonary fibrosis, etc.)
  • Chronic renal disease (eg: renal failure)
  • Obesity (BMI ≥ 30)
  • Progressive cancer under treatment
  • Chronic haematological pathology
  • Chronic liver disease (eg: cirrhosis)
  • HIV infection / other immune deficiency (congenital or acquired immunosuppression)
  • Has received an organ or bone marrow transplant
  • Chronic neurological abnormality / disease
  • Immunosuppression
  • Subject having his 2nd injection of COVID-19 vaccine scheduled during the 3 weeks of study follow-up
  • Taking part in another interventional clinical trial or in the exclusion period to another study
  • Those who do not have access to email/internet
  • Not capable of giving informed consent
  • Hypersensitivity or known allergy to any component of the product
  • Patient with a member of his household already included in the study
  • Patient living in another region than the recruiting laboratory

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
No Intervention: control group
Experimental: Active group
Physiomer®, undiluted seawater nasal spray
Device: Device: Physiomer undiluted seawater nasal spray

In this study, subjects are asked to adhere to the following dosage during the 3 weeks of the study:

  • Nasal wash four times every day
  • These washes are to be carried out in each nostril
  • By continuously pressing the spray for 3 seconds in each nostril

  • Subjects are recommended to distribute the 4 nasal washes as follows:

    • 1st : morning
    • 2nd : midday
    • 3rd : afternoon
    • 4th : evening Subjects will be instructed to maintain daily nasal wash over the 3 weeks study period even in case of earlier nasal symptoms resolution, in order to assess the impact of nasal wash on viral load and other symptoms.

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
number of days until resolution of nasal symptoms
Time Frame: From Day 0 to Day 21
the number of days until resolution of nasal symptoms (nasal obstruction or rhinorrhea) based on the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) self-questionnaire modified for COVID-19 symptoms.
From Day 0 to Day 21

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
COVID-19 exacerbation
Time Frame: From Day 0 to Day 21
percent of subjects with evolution towards more severe COVID-19 stage from Day 0 to Day 21 as defined by the NIH COVID-19 Treatment Guidelines classification (Clinical Spectrum of SARS-CoV-2 Infection)
From Day 0 to Day 21
Symptom relief
Time Frame: From Day 0 to Day 21
• percent of subjects with complete relief from Day 1 to Day 21 based on a 7-point scale: 0 (no relief) to 6 (complete relief).
From Day 0 to Day 21
Olfactory disorders
Time Frame: From Day 0 to Day 21
  • percent of subjects with recovery from anosmia & smell disorders from Day 0 to Day 21 based on a 0 to 7 severity scale, where 0 = do not have this symptom, and 7 = Severe.
  • percent of subjects with recovery from taste disorders from Day 0 to Day 21 based on a 0 to 7 severity scale, where 0 = do not have this symptom, and 7 = Severe.
From Day 0 to Day 21
Compliance to nasal wash
Time Frame: From Day 0 to Day 21

The following endpoints are only applicable to subjects randomized to the interventional arm of the study:

  • Number of nasal wash/day from Day 0 to Day 21
  • Number of days of use/week from Day 0 to Day 21 Number of subjects using the advised volume/nasal wash from Day 0 to Day 21
From Day 0 to Day 21
Patient satisfaction
Time Frame: at Day 7, Day 14 and Day 21

The following endpoints are only applicable to subjects randomized to the interventional arm of the study:

• Product satisfaction (overall satisfaction, overall perceived efficacy) measured at Day 7, Day 14 and Day 21 based on a 5-point scale with 0=Not at all satisfied, and 4=Very satisfied.
at Day 7, Day 14 and Day 21
Nasal wash tolerance
Time Frame: From Day 0 to Day 21

The following endpoints are only applicable to subjects randomized to the interventional arm of the study:

• Self-reported tolerance with nasal wash from Day 0 to Day 21: nasal burning, nasal irritation, nasal itching, nasal bleeding (epistaxis), nasal dryness based on a 7-point scale with 0= no difficulty, and 6=very unacceptable.
From Day 0 to Day 21
Incidence of Adverse Events/Side Effects
Time Frame: From Day 0 to Day 21

• Adverse Events reported by all subjects from Day 0 to Day 21

The following endpoint is only applicable to subjects randomized to the interventional arm of the study:

• Side effects reported by subjects from Day 0 to Day 21
From Day 0 to Day 21
Symptom resolution
Time Frame: From Day 0 to Day 21
the number of days until resolution of COVID-19 and URTIs-induced individual symptoms based on the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) self-questionnaire modified for COVID-19 symptoms.
From Day 0 to Day 21
Viral load evolution
Time Frame: Day 0, Day 3, Day 5, Day 14 and Day 21
• percent of subjects with negative RT-PCR for SARS-CoV-2 and URTI viruses by Day 3, Day 5, Day 14 & Day 21
Day 0, Day 3, Day 5, Day 14 and Day 21
Reported illness days & missed days
Time Frame: From Day 0 to Day 21
  • Number of illness days from Day 0 to Day 21 based on the WURSS-21 self-questionnaire modified for COVID-19 symptoms.
  • Reported missed working days from Day 0 to Day 21
  • Reported missed days of activities from Day 0 to Day 21
From Day 0 to Day 21
Concomitant medications
Time Frame: From Day 0 to Day 21
Number of days of intake of concomitant medications to relieve symptoms from Day 0 to Day 21 Number of concomitant medications used per day to relieve symptoms from Day 0 to Day 21
From Day 0 to Day 21
Transmission within household contacts
Time Frame: From Day 0 to Day 21
  • percent of clinical manifestations of COVID-19 and URTIs in household contacts
  • percent of SARS-CoV-2 positive cases among household contacts within the incubation period and during the 21 days follow-up period based on questionnaires from the WHO "household transmission investigation protocol for 2019-novel coronavirus (COVID-19)"
From Day 0 to Day 21
Health-care-seeking behaviour
Time Frame: From Day 0 to Day 21
  • percent of subjects consulting a HCP due to their COVID-19 and URTI status from Day 0 to Day 21
  • percent of subjects requiring biological or radiological examinations due to COVID-19 and URTI from Day 0 to Day 21
  • percent of hospitalized subjects due to COVID-19 and URTI from Day 0 to Day 21
From Day 0 to Day 21

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.
Laboratoire de la Mer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
EVAMED

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara PERNICONI

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.
July 29, 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.
March 18, 2022

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.
March 18, 2022

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).
May 31, 2021

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.
June 4, 2021

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.
June 7, 2021

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.
July 3, 2023

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.
June 28, 2023

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.
June 1, 2023

More Information

Terms related to this study

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.
  • SeaCare

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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