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

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ClinicalTrials.gov Identifier: NCT04357990
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kerecis Ltd.

Tracking Information
First Submitted Date  ICMJE April 20, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE September 4, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • 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.
  • Number of adverse events per group [ Time Frame: 28 days ]
    The number of adverse events reported will be compared between groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Viruxal Oral and Nasal Spray
    The Device will be administered to the oral and nasal passages, three times per day.
    Intervention: Device: Viruxal Oral and Nasal Spray
  • Placebo Comparator: Placebo
    The placebo will be administered to the oral and nasal passages, three times per day.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
128
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2020)
81
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ragnar F Ingvarsson, MD +354 824 6017 ragnari@landspitali.is
Listed Location Countries  ICMJE Iceland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04357990
Other Study ID Numbers  ICMJE KS-0470
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kerecis Ltd.
Study Sponsor  ICMJE Kerecis Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ragnar F Ingvarsson, MD Landspitalinn University Hospital, Iceland
PRS Account Kerecis Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP