Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 (KONS-COVID19)

Kerecis

Status: Completed

Conditions: COVID-19

Treatments: Device: Viruxal Oral and Nasal Spray; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04357990

KS-0470

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Viruxal Oral and Nasal Spray

Experimental group

Description:

The Device will be administered to the oral and nasal passages, three times per day.

Treatment:

Device: Viruxal Oral and Nasal Spray

Placebo

Placebo Comparator group

Description:

The placebo will be administered to the oral and nasal passages, three times per day.

Treatment:

Other: Placebo