Status:
COMPLETED
Seawater Nasal Wash to Relieve COVID-19 Nasal Symptoms and Reduce SARS-CoV-2 Viral Load.
Lead Sponsor:
Laboratoire de la Mer
Collaborating Sponsors:
EVAMED
Conditions:
SARS-CoV2 Infection (COVID-19)
URTI - Viral Upper Respiratory Tract Infection
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 airbor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04916639
Start Date
July 29 2021
End Date
March 18 2022
Last Update
July 3 2023
Active Locations (1)
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1
Le Carreau
Cergy, France, 95000