NCT04916639

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 31, 2021

Last Update Submit

June 28, 2023

Conditions

SARS-CoV2 Infection (COVID-19)URTI - Viral Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

  • number of days until resolution of nasal symptoms

    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 Outcomes (13)

  • Symptom resolution

    From Day 0 to Day 21

  • COVID-19 exacerbation

    From Day 0 to Day 21

  • Symptom relief

    From Day 0 to Day 21

  • Viral load evolution

    Day 0, Day 3, Day 5, Day 14 and Day 21

  • Olfactory disorders

    From Day 0 to Day 21

  • +8 more secondary outcomes

Study Arms (2)

Active group

EXPERIMENTAL

Physiomer®, undiluted seawater nasal spray

Device: Device: Physiomer undiluted seawater nasal spray

control group

NO INTERVENTION

Interventions

Device: Physiomer undiluted seawater nasal sprayDEVICE

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.

Active group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age over 65 years
  • Subjects requiring hospitalization
  • Subjects with severe COVID-19 symptoms
  • Inability or unwillingness to perform saline irrigations
  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Carreau

Cergy, 95000, France

Location

Related Publications (1)

  • de Gabory L, Vallet S, Naelten G, Raherison-Semjen C. Seawater nasal wash to reduce symptom duration and viral load in COVID-19 and upper respiratory tract infections: a randomized controlled multicenter trial. Eur Arch Otorhinolaryngol. 2024 Jul;281(7):3625-3637. doi: 10.1007/s00405-024-08518-y. Epub 2024 Feb 20.

    PMID: 38376591DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Barbara PERNICONI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 7, 2021

Study Start

July 29, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

FR(1)