NCT04357990

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

Use of a Medical Device, Viruxal Oral and Nasal Spray, for Treating the Symptoms of COVID-19 Via Application to the Naso- and Oropharyngeal Mucosa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Kerecis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Placebo	The placebo will be a similar spray containing saline only.

Timeline

• Start date: 2020-09-04
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2020-04-22
• Last updated: 2022-07-06

Locations

1 site across 1 country: Iceland