Summary
This study aims to evaluate the effectiveness of a seawater nasal spray in reducing the duration of nasal symptoms of COVID-19 and reducing the SARS-CoV-2 viral load in subjects with mild to moderate COVID-19, and the study will take place in France among adults subjects with mild to moderate COVID-19 who developed nasal obstruction and rhinorrhea no more than 48 hours before study inclusion.
Key points
- A medical trial is being conducted to assess the efficacy of a natural seawater nasal spray, Physiomer®, to reduce duration of COVID-19 nasal symptoms and reduce SARS-CoV-2 viral load in subjects with mild to moderate COVID-19 disease.
- Nasal saline irrigations are frequently prescribed for both prevention and treatment of upper respiratory tract infections (URTIs).
- The sponsor hypothesized that the daily use of seawater nasal wash in subjects with mild to moderate forms of COVID-19 would relieve nasal symptoms caused by SARS-CoV-2 virus, including nasal obstruction and rhinorrhea, and would reduce the intranasal viral load.
- The study will take place in France among adults subjects with mild to moderate COVID-19 who developed nasal obstruction and rhinorrhea no more than 48 hours before study inclusion.
- Subjects positive for SARS-CoV-2 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.
- 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 of COVID-19 (nasal obstruction or rhinorrhea) in subjects with mild to moderate COVID-19.
- The study is estimated to start on May 27, 2021, and end on October 27, 2021.
Randomized, controlled, multicenter, parallel group trial to assess the efficacy of Physiomer®, a natural seawater nasal spray, to reduce duration of COVID-19 nasal symptoms and reduce SARS-CoV-2 viral load in subjects with mild to moderate COVID-19 disease.
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:
- Would relieve nasal symptoms caused by SARS-CoV-2 virus, including nasal obstruction and rhinorrhea.
- Would reduce the intranasal viral load by mechanical evacuation of nasal secretions containing the SARS-CoV-2 virus, and by reducing the contact time between the SARS-COV-2 virus 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 of COVID-19 (nasal obstruction or rhinorrhea) in subjects with mild to moderate COVID-19.
The study will take place in France among adults subjects with mild to moderate COVID-19 who developed nasal obstruction and rhinorrhea no more than 48 hours before study inclusion. Subjects positive for SARS-CoV-2 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 nasal SARS-CoV-2 viral load, 4 naso-pharyngeal swabs will be collected at home by a nurse.
Study Design
Resource links provided by the National Library of Medicine
MedlinePlus (opens in a new tab) related topics: COVID-19 (Coronavirus Disease 2019) (opens in a new tab)
U.S. FDA Resources (opens in a new tab)
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
number of days until resolution of COVID-19-induced nasal symptoms [ Time Frame: From Day 0 to Day 21 ]the number of days until resolution of COVID-19-induced nasal symptoms (nasal obstruction or rhinorrhea) based on the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) self-questionnaire modified for COVID-19 symptoms. Secondary Outcome Measures :
Symptom resolution [ Time Frame: From Day 0 to Day 21 ]the number of days until resolution of COVID-19-induced individual symptoms based on the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) self-questionnaire modified for COVID-19 symptoms.
COVID-19 exacerbation [ Time Frame: From Day 0 to Day 21 ]percent of subjects with evolution towards more severe COVID-19 stage from Day 0 to Day 21 as defined by the NIH COVID-19 Treatment Guidelines classification (Clinical Spectrum of SARS-CoV-2 Infection)
Symptom relief [ Time Frame: From Day 0 to Day 21 ]• percent of subjects with complete relief from Day 1 to Day 21 based on a 7-point scale: 0 (no relief) to 6 (complete relief).
Viral load evolution [ Time Frame: Day 0, Day 3, Day 5, Day 14 and Day 21 ]• percent of subjects with negative RT-PCR for SARS-CoV-2 by Day 3, Day 5, Day 14 & Day 21
Olfactory disorders [ Time Frame: From Day 0 to Day 21 ]
- percent of subjects with recovery from anosmia & smell disorders from Day 0 to Day 21 based on a 0 to 7 severity scale, where 0 = do not have this symptom, and 7 = Severe.
- percent of subjects with recovery from taste disorders from Day 0 to Day 21 based on a 0 to 7 severity scale, where 0 = do not have this symptom, and 7 = Severe.
- Reported illness days & missed days [ Time Frame: From Day 0 to Day 21 ]
- Number of illness days from Day 0 to Day 21 based on the WURSS-21 self-questionnaire modified for COVID-19 symptoms.
- Reported missed working days due to COVID-19-illness/symptoms from Day 0 to Day 21
- Reported missed days of activities due to COVID-19-illness/symptoms from Day 0 to Day 21
- Concomitant medications [ Time Frame: From Day 0 to Day 21 ]Number of days of intake of concomitant medications to relieve COVID-19 symptoms from Day 0 to Day 21 Number of concomitant medications used per day to relieve COVID-19 symptoms from Day 0 to Day 21
- Transmission within household contacts [ Time Frame: From Day 0 to Day 21 ]
- percent of clinical manifestations of COVID-19 in household contacts
- percent of SARS-CoV-2 positive cases among household contacts within the incubation period and during the 21 days follow-up period based on questionnaires from the WHO "household transmission investigation protocol for 2019-novel coronavirus (COVID-19)"
- Health-care-seeking behaviour [ Time Frame: From Day 0 to Day 21 ]
- percent of subjects consulting a HCP due to their COVID-19 status from Day 0 to Day 21
- percent of subjects requiring biological or radiological examinations due to COVID-19 from Day 0 to Day 21
- percent of hospitalized subjects due to COVID-19 from Day 0 to Day 21
- Compliance to nasal wash [ Time Frame: From Day 0 to Day 21 ] The following endpoints are only applicable to subjects randomized to the interventional arm of the study:
- Number of nasal wash/day from Day 0 to Day 21
- Number of days of use/week from Day 0 to Day 21 Number of subjects using the advised volume/nasal wash from Day 0 to Day 21
- Patient satisfaction [ Time Frame: at Day 7, Day 14 and Day 21 ] The following endpoints are only applicable to subjects randomized to the interventional arm of the study:
- Product satisfaction (overall satisfaction, overall perceived efficacy) measured at Day 7, Day 14 and Day 21 based on a 5-point scale with 0=Not at all satisfied, and 4=Very satisfied.
- Nasal wash tolerance [ Time Frame: From Day 0 to Day 21 ] The following endpoints are only applicable to subjects randomized to the interventional arm of the study:
- Self-reported tolerance with nasal wash from Day 0 to Day 21: nasal burning, nasal irritation, nasal itching, nasal bleeding (epistaxis), nasal dryness based on a 7-point scale with 0= no difficulty, and 6=very unacceptable.
- Incidence of Adverse Events/Side Effects [ Time Frame: From Day 0 to Day 21 ]
Adverse Events reported by all subjects from Day 0 to Day 21 The following endpoint is only applicable to subjects randomized to the interventional arm of the study:
- Side effects reported by subjects from Day 0 to Day 21 Eligibility Criteria
Information from the National Library of Medicine
*Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, *Learn About Clinical Studies. (opens in a new tab)
Criteria
Inclusion Criteria:
Adult subjects (≥ 18 years) testing positive for COVID-19 (rapid antigenic test) with self-reported nasal obstruction & rhinorrhea ≤48 hours
Subjects with mild to moderate COVID-19 symptoms
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 Criteria:
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
Hypertension
Cardiovascular pathologies: history of stroke, history of coronary artery disease, history of cardiac surgery, NYHA stage III or IV heart failure;
Diabetes
Smokers
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 who received at least one dose of any COVID-19 vaccine
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 department than the recruiting laboratory Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
*Please refer to this study by its ClinicalTrials.gov identifier (NCT number): *NCT04916639