Washing COVID-19 Away With a Hypertonic Seawater Nasal Irrigation Solution
Condition: SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Nasal irrigations are thought to reduce the amount of virus from the nasal cavity. The aim of
      the present study is to evaluate the effect of a hypertonic seawater solution containing
      algal and herbal natural ingredients (Sinomarin®) on the nasopharyngeal viral load in
      hospitalized patients with severe COVID-19 pneumonia. The investigators will conducted a
      prospective, randomized, controlled trial. Patients will be allocated in two groups, the
      hypertonic seawater group receiving nasal irrigations with a hypertonic seawater solution
      (Sinomarin®) every 4 hours during a 16-hour interval per day, for two consecutive days, and
      the control group (no nasal irrigations). Forty-eight hours after the baseline nasopharyngeal
      swab (and 8 hours after the last wash in the hypertonic seawater group), a second
      nasopharyngeal swab will be collected for the semiquantitative estimation of the SARS-CoV-2
      viral load as determined by cycle threshold (Ct) values.
    

Detailed description: 
      Investigators will perform a prospective, randomized, controlled study in 56 patients with
      confirmed COVID-19 pneumonia. All patients will be treated with the standard protocol of care
      for COVID-19 at the Department of Infectious Diseases and will be randomized into one of two
      groups with the method of sequentially numbered, opaque, sealed envelopes, the hypertonic
      seawater group (will receive a hypertonic (2.3% NaCl) seawater solution containing brown
      algae (Undaria pinnatifida) and blue-green algae (Spirulina platensis) as well as essential
      oils of Eucalyptus globulus and Mentha spicata, and Thymus vulgaris extract (Sinomarin® Plus
      Algae Cold & Flu Relief, Gerolymatos International SA, Krioneri, Greece)) and the control
      group (no treatment). Sinomarin® is a medical device that utilizes continuous flow diffusion.
      The solution continues to flow as long as the nozzle is pressed, providing efficient
      cleansing.

      At admission, a baseline nasopharyngeal swab will be collected from all patients and placed
      in a sterile bottle containing virus transport medium (10 ml tube with 3 ml medium, Biobase,
      Biodustry, Shandong, China) for SARS-CoV-2 nucleic acid detection (zero hour). Patients in
      the hypertonic seawater group will be given a review on the proper technique for nasal
      irrigation. Specifically, they will be instructed to blow their nose before irrigation,
      gently bend their neck forward, tilt their head to one side, and insert the nozzle into the
      nostril in line with the nasal septum. They will be advised to press firmly on the nozzle to
      squirt the solution into the nostril and then repeat the process on the other nostril. The
      patients will also be instructed to spit out any solution coming into their mouth and then
      return to an upright position to allow the solution to work for a few seconds before blowing
      their nose gently. After each use, they will be advised to remove the nozzle from the bottle,
      wash it thoroughly with warm water, and wipe it dry. Thereafter, patients will be given one
      bottle of 200 ml Sinomarin® and will be instructed to perform nasal irrigation to each
      nostril every 4 hours for a 16-hour period per day, for two consecutive days.

      Forty-eight hours after the baseline nasopharyngeal swab and 8 hours after the last nasal
      wash, a second nasopharyngeal swab will be collected for viral load measurement. All
      nasopharyngeal swabs will be collected by a physician blinded to group allocation and will be
      collected from the same nostril for each patient.

      Demographic data including age, sex, nationality, body mass index, smoking status, and date
      of admission will be collected at baseline. Data on comorbidities, Charlson comorbidity
      index, disease related symptoms, vaccination status, presenting day of illness since symptom
      onset, oxygenation status (PaO2/FiO2), and medication administered will also be recorded.
      Furthermore, outcome and potential adverse effects related to use of hypertonic seawater
      solution containing algal and herbal natural ingredients will be recorded. All patients will
      be followed until hospital discharge, ICU admission, or death. Those that will be discharged
      will be reexamined 14 days after hospital discharge for real-time polymerase chain reaction
      (RT-PCR). Manual chart review will be used to gather details of the laboratory studies,
      course, and outcomes.
    

Intervention name(s): Hypertonic seawater solution
Intervention type(s): Other
Intervention description(s): Nasal irrigations with hypertonic seawater solution
Other intervention name(s): Sinomarin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Nasal irrigation; Hypertonic seawater solution; SARS-CoV2; Viral load