Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19

NCT ID: NCT04357990

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2020-10-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Viruxal Oral and Nasal Spray

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

Group Type: EXPERIMENTAL

Viruxal Oral and Nasal Spray

Intervention Type: DEVICE

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo will be a similar spray containing saline only.

Interventions

Viruxal 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.

Intervention Type: DEVICE

Placebo

The placebo will be a similar spray containing saline only.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kerecis Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ragnar F Ingvarsson, MD

Role: PRINCIPAL_INVESTIGATOR

Landspitalinn University Hospital, Iceland

Locations

National Hospital of Iceland (Landspítali)

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

KS-0470

Identifier Type: -

Identifier Source: org_study_id