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NCT Number: NCT04357990

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital of Iceland (Landspítali)

Reykjavik, 101, Iceland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Other

The placebo will be a similar spray containing saline only.

Primary outcomes

  1. Number of days until complete resolution of symptoms per group

    Time frame: 28 days

    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.

  2. Number of hospital admissions per group

    Time frame: 28 days

    The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups.

Secondary outcomes

  1. Number of days until a reduction in symptoms per group

    Time frame: 28 days

    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.

  2. Number of adverse events per group

    Time frame: 28 days

    The number of adverse events reported will be compared between groups.

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Registry information

Official study title

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

Acronym: KONS-COVID19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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