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

NCT04357990 | Completed DMC

• 1 other identifier: KS-0470
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of days until a reduction in symptoms per group

  28 days

• Number of adverse events per group

  28 days

Study Arms (2)

Viruxal Oral and Nasal Spray

EXPERIMENTAL

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

Device: Viruxal Oral and Nasal Spray

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Viruxal Oral and Nasal Spray 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.

Viruxal Oral and Nasal Spray

Placebo OTHER

The placebo will be a similar spray containing saline only.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kerecis Ltd.: lead

Study Sites (1)

National Hospital of Iceland (Landspítali)

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ragnar F Ingvarsson, MD

  Landspitalinn University Hospital, Iceland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: September 4, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)