Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 (KONS-COVID19)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Viruxal Oral and Nasal Spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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
Sites / Locations
- National Hospital of Iceland (Landspítali)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Viruxal Oral and Nasal Spray
Placebo
Arm Description
The Device will be administered to the oral and nasal passages, three times per day.
The placebo will be administered to the oral and nasal passages, three times per day.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Number of adverse events per group
The number of adverse events reported will be compared between groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357990
Brief Title
Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19
Acronym
KONS-COVID19
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kerecis Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viruxal Oral and Nasal Spray
Arm Type
Experimental
Arm Description
The Device will be administered to the oral and nasal passages, three times per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will be administered to the oral and nasal passages, three times per day.
Intervention Type
Device
Intervention Name(s)
Viruxal Oral and Nasal Spray
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo will be a similar spray containing saline only.
Primary Outcome Measure Information:
Title
Number of days until complete resolution of symptoms per group
Description
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.
Time Frame
28 days
Title
Number of hospital admissions per group
Description
The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of days until a reduction in symptoms per group
Description
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.
Time Frame
28 days
Title
Number of adverse events per group
Description
The number of adverse events reported will be compared between groups.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragnar F Ingvarsson, MD
Organizational Affiliation
Landspitalinn University Hospital, Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital of Iceland (Landspítali)
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19
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