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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: Viruxal Oral and Nasal Spray Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357990


Contacts
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Contact: Ragnar F Ingvarsson, MD +354 824 6017 ragnari@landspitali.is

Locations
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Iceland
National Hospital of Iceland (Landspítali) Recruiting
Reykjavík, Iceland, 101
Contact: Ragnar F Ingvarsson, MD    +354 824 6017    ragnari@landspitali.is   
Sponsors and Collaborators
Kerecis Ltd.
Investigators
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Principal Investigator: Ragnar F Ingvarsson, MD Landspitalinn University Hospital, Iceland
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Responsible Party: Kerecis Ltd.
ClinicalTrials.gov Identifier: NCT04357990    
Other Study ID Numbers: KS-0470
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases