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

NCT04916639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Laboratoire de la Mer

    lead INDUSTRY

Principal Investigators

  • Barbara PERNICONI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2022-03-18
Completion
2022-03-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916639 on ClinicalTrials.gov