COVID-19KONS-COVID19NCT04357990
Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19
A study testing Viruxal Oral and Nasal Spray in people with COVID-19, run by Kerecis Ltd. at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Viruxal Oral and Nasal Spray
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteIceland
- Study dates
- 4 Sep 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Viruxal Oral and Nasal Spray, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viruxal Oral and Nasal SprayDevice
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.
PlaceboOther
The placebo will be a similar spray containing saline only.
| Study group | Role | What they receive |
|---|---|---|
| Viruxal Oral and Nasal Spray | Experimental | The Device will be administered to the oral and nasal passages, three times per day. Receives: Device: Viruxal Oral and Nasal Spray |
| Placebo | Placebo comparator | The placebo will be administered to the oral and nasal passages, three times per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Secondary outcomes (2)
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.
Measured: 28 days
Number of adverse events per group
The number of adverse events reported will be compared between groups.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start4 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ragnar F Ingvarsson, MD, Principal investigator, Landspitalinn University Hospital, Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357990
- Sponsor's protocol ID
- KS-0470
- Acronym
- KONS-COVID19
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04357990
- Acronym / sponsor ID
- KONS-COVID19 / KS-0470
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viruxal Oral and Nasal Spray | Experimental | Device: Viruxal Oral and Nasal SprayThe Device will be administered to the oral and nasal passages, three times per day. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo will be administered to the oral and nasal passages, three times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viruxal Oral and Nasal SprayViruxal 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. | Device | Viruxal Oral and Nasal Spray |
| PlaceboThe placebo will be a similar spray containing saline only. | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
Number of days until a reduction in symptoms per group
Time frame: 28 days
Number of adverse events per group
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnar F Ingvarsson, MD principal investigator
Landspitalinn University Hospital, Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viruxal Oral and Nasal Spray in people with COVID-19, run by Kerecis Ltd. at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days until complete resolution of symptoms per group (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.