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Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy (VIRNEO)

Primary Purpose

Common Cold

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Resveratrol and Carbossimetyl Beta Glucan
Saline Solution
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

1 Day - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • common cold syndrome

Exclusion Criteria:

  • main comorbidities

Sites / Locations

  • Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol and Carbossimetyl Beta Glucan

Saline solution

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Detection of Rinovirus in the nasal secretions
Difference in Human Rhinovirus replication will by the use of nasal swab analysis.
30-day relapses
Number of relapses

Full Information

First Posted
March 7, 2018
Last Updated
March 18, 2019
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03683108
Brief Title
Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
Acronym
VIRNEO
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol and Carbossimetyl Beta Glucan
Arm Type
Experimental
Arm Title
Saline solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Resveratrol and Carbossimetyl Beta Glucan
Intervention Description
Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.
Primary Outcome Measure Information:
Title
Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
Description
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.
Time Frame
enrollment, after 48 hours and after 7 and 30 days
Secondary Outcome Measure Information:
Title
Detection of Rinovirus in the nasal secretions
Description
Difference in Human Rhinovirus replication will by the use of nasal swab analysis.
Time Frame
after 48 hours and 7 days
Title
30-day relapses
Description
Number of relapses
Time Frame
30-day after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: common cold syndrome Exclusion Criteria: main comorbidities
Facility Information:
Facility Name
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy

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