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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: Viruxal Oral and Nasal Spray; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík, Iceland, 101
    • National Hospital of Iceland (Landspítali)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viruxal Oral and Nasal Spray; The Device will be administered to the oral and nasal passages, three times per day.	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.
Placebo Comparator: Placebo; The placebo will be administered to the oral and nasal passages, three times per day.	Other: Placebo; The placebo will be a similar spray containing saline only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days until complete resolution of symptoms per group	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.	28 days
Number of hospital admissions per group	The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days until a reduction in symptoms per group	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.	28 days
Number of adverse events per group	The number of adverse events reported will be compared between groups.	28 days

Collaborators and Investigators

• Sponsor: Kerecis Ltd.
• Investigators: Principal Investigator: Ragnar F Ingvarsson, MD, Landspitalinn University Hospital, Iceland

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KS-0470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No