Common ColdPhase 3VIRNEONCT03683108
Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
A Phase 3 study testing Resveratrol and Carbossimetyl Beta Glucan and Saline Solution in people with Common Cold, run by Policlinico Hospital at 1 site in Italy.
Trial summary
outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention: A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution. Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- Resveratrol and Carbossimetyl Beta Glucan and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Mar 2018
- Phase
- Phase 3
- 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 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- common cold syndrome
Who cannot join
- main comorbidities
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, 70124
About this study
Official title: Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention:
A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution.
Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.
Read the detailed description
Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days).
Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days.
Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.
- Conditions
- Common Cold
- Being tested
- Resveratrol and Carbossimetyl Beta Glucan, Saline Solution
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol and Carbossimetyl Beta GlucanDrug
Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.
Saline SolutionOther
Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol and Carbossimetyl Beta Glucan | Experimental | Not described Receives: Drug: Resveratrol and Carbossimetyl Beta Glucan |
| Saline solution | Placebo comparator | Not described Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
The CARIFS score consisted of 18 items each answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3).
Some CARIFS items such as "headache", "sore-throat", "muscle aches or pains" were not applicable to infants. The mean of the point of all applicable items was considered as a measure of child's overall illness level.
Measured: enrollment, after 48 hours and after 7 and 30 days
Secondary outcomes (2)
Detection of Rinovirus in the nasal secretions
Difference in Human Rhinovirus replication will by the use of nasal swab analysis.
Measured: after 48 hours and 7 days
30-day relapses
Number of relapses
Measured: 30-day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study startDec 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683108
- Sponsor's protocol ID
- VIRNEO1
- Acronym
- VIRNEO
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
- ClinicalTrials.gov ID
- NCT03683108
- Acronym / sponsor ID
- VIRNEO / VIRNEO1
- Conditions
- Common Cold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Sep 2018 (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.
outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention:
A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution.
Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.
Detailed description
Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days).
Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days.
Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol and Carbossimetyl Beta Glucan | Experimental | Drug: Resveratrol and Carbossimetyl Beta Glucan |
| Saline solution | Placebo comparator | Other: Saline Solution |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- common cold syndrome
Key exclusion criteria (1 listed)
- main comorbidities
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 |
|---|---|---|
| Resveratrol and Carbossimetyl Beta GlucanMedical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week. | Drug | Resveratrol and Carbossimetyl Beta Glucan |
| Saline SolutionMedical device based on Saline Solution. 3 drops, 4 times a day for 1 week. | Other | Saline solution |
Primary outcome
Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
Time frame: enrollment, after 48 hours and after 7 and 30 days
The CARIFS score consisted of 18 items each answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3). Some CARIFS items such as "headache", "sore-throat", "muscle aches or pains" were not applicable to infants. The mean of the point of all applicable items was considered as a measure of child's overall illness level.
2 secondary outcomes
Detection of Rinovirus in the nasal secretions
Time frame: after 48 hours and 7 days
30-day relapses
Time frame: 30-day after treatment
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 20 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resveratrol and Carbossimetyl Beta Glucan and Saline Solution in people with Common Cold, run by Policlinico Hospital at 1 site in Italy.
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 1 inclusion and 1 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 20 Mar 2019. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Canadian Acute Respiratory Illness and Flu Scale (CARIFS) (time frame: enrollment, after 48 hours and after 7 and 30 days). 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 20 Mar 2019.