COVID-19
Conditions
Brief summary
Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf (the Device). A double blind clinical trial will be conducted to evaluate the Device against placebo in COVID-19 positive, symptomatic patients in Iceland. Immediate access to COVID-19 patients is available through a well-organized COVID-19 outpatient follow-up clinic. Up to 128 patients with mild to moderate symptoms of COVID-19 will be recruited (so called higher end of the low risk group). These patients will be positive for COVID-19, be symptomatic with upper respiratory symptoms, but without involvement of the entire respiratory system. The patients will be randomized to receive treatment with the Study Device or to receive placebo. 64 patients will be randomized into the Study Device group and 64 patients into the Control group. Patients will administer Study Device or Control for 14 days and will have their symptoms recorded until no further symptoms are reported, up to a maximum of 28 days follow-up.
Interventions
DEVICEViruxal Oral and Nasal Spray
Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf. The Device contains Omega3 Viruxide. The main components in Omega3 Viruxide are Neem oil and St. John's Wort oil. The Device is administered from a pressurized canister into the oral and nasal cavity, where it creates a physical barrier for temporary protection of the mucosal tissue.
OTHERPlacebo
The placebo will be a similar spray containing saline only.
Sponsors
Kerecis Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * Positive for SARS-CoV-2 infection * Has symptoms of upper respiratory infection * Willing to participate in the clinical trial and gives consent * Is not pregnant, nor actively trying to conceive a child.
Exclusion criteria
* Under 18 years of age * Negative for SARS-CoV-2 infection * Severe symptoms of infection * Symptoms involving the entire respiratory system, including Pneumonia * Requires hospitalisation prior to study start * Asymptomatic * Pregnant or actively trying to conceive a child * Other comorbidities that would prevent administration of the device * Requirement to take regular medications administered by inhalation, or via the naso- and oropharyngeal route * Patients with known allergies to Neem or Hypericum oil * Patients with asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days until complete resolution of symptoms per group | 28 days | The number of days until participants report no symptoms, which they attribute to COVID-19, will be compared between groups. Symptoms include: Fever (38.0°C or higher), chills, dry cough, cough with rise, shortness of breath (rest), shortness of breath (Exercise), dyspnoea, sore throat, runny nose, headache, myalgia/bone pain, anorexia, nausea, vomiting, loss of smell, osteoporosis, abdominal pain, diarrhea, weakness. |
| Number of hospital admissions per group | 28 days | The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days until a reduction in symptoms per group | 28 days | The number of days until participants report a reduction in symptoms, which they attribute to COVID-19, will be compared between groups. Symptoms include: Fever (38.0°C or higher), chills, dry cough, cough with rise, shortness of breath (rest), shortness of breath (Exercise), dyspnoea, sore throat, runny nose, headache, myalgia/bone pain, anorexia, nausea, vomiting, loss of smell, osteoporosis, abdominal pain, diarrhea, weakness. |
| Number of adverse events per group | 28 days | The number of adverse events reported will be compared between groups. |
Countries
Iceland
Outcome results
None listed