Seawater Nasal Wash to Relieve COVID-19 Nasal Symptoms and Reduce SARS-CoV-2 Viral Load.
Condition: SARS-CoV2 Infection (COVID-19); URTI - Viral Upper Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections
Study type: Interventional

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.
    

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.
    

Intervention name(s): Device: Physiomer undiluted seawater nasal spray
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment