This trial will compare to a placebo (inactive treatment) the efficacy and safety of a mixture of antibodies raised against a key protein of the immune system (TLR3) used in homoepathic dilutions in patients suffering from common cold. The trial will be conducted in multiple centres. Treatment assignment will be done by chance.

Multicentre, randomised, double-blind, parallel, placebo-controlled study evaluating the efficacy and safety of Early Self-Treatment of viral Upper respiratory tract infections with homeopathic oral Antibodies to the TLR3 FYW peptide (TAO1) - ESTUAR Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000057-31-BE

Enrollment

Unknown

Registered

2012-01-31

Start date

2012-03-19

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral upper respiratory tract infections MedDRA version: 14.1 Level: PT Classification code 10022004 Term: Influenza like illness System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: LLT Classification code 10010106 Term: Common cold System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10000938 Term: Acute nasopharyngitis (common cold) System Organ Class: 10021881 - Infections

Interventions

Product Name: TAO1 Pharmaceutical Form: Sublingual tablet Current Sponsor code: TAO1 Concentration unit: Other Concentration type: equal Concentration number: C12+C30+C200- Pharmaceutical form of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Outpatients aged > or = 18 years b) Ability and willingness to adhere to the study protocol c) Signed informed consent d) Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?" e) At least one of the following 4 common cold symptoms: sneezing, runny nose, nasal obstruction and/or sore throat, with no limitations of symptom severity. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: a) Specific chronic diseases (autoimmune disease, chronic bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis) b) Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. c) Cancer therapy d) Immunosuppressant therapies e) Use of systemic corticosteroids f) A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing) g) Any of the common cold symptoms persisting since more than 36 hours h) Use of other homeopathic drugs designed to treat URTIs i) Use of antibiotics, anti-histaminergic drugs or decongestants j) Participation in another clinical trial within one month prior to treatment start k) Previous participation (receipt of randomised treatment) in this study

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults;Secondary Objective: a) To evaluate the efficacy of TAO1 in reducing the duration of common cold b) To evaluate the impact of TAO1 on health-related Quality of Life (functional impairment) in patients with common cold c) To evaluate the safety of TAO1;Primary end point(s): Severity of symptoms of common cold: Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (of the sum of all WURSS scores over the follow-up). A 30% reduction in AUC versus placebo will be regarded as clinically significant;Timepoint(s) of evaluation of this end point: WURSS-21 questionnaire completed on a daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold	—

Measure

Time frame

Main Objective: To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults;Secondary Objective: a) To evaluate the efficacy of TAO1 in reducing the duration of common cold b) To evaluate the impact of TAO1 on health-related Quality of Life (functional impairment) in patients with common cold c) To evaluate the safety of TAO1;Primary end point(s): Severity of symptoms of common cold: Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (of the sum of all WURSS scores over the follow-up). A 30% reduction in AUC versus placebo will be regarded as clinically significant;Timepoint(s) of evaluation of this end point: WURSS-21 questionnaire completed on a daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold

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Secondary

Measure	Time frame
Secondary end point(s): a) Duration of common cold: Duration is defined as the number of days from self-reported onset of disease to the last day before the participant answered “Not sick” to the question, “How sick do you feel today?”. A 2-day reduction in average disease duration versus placebo will be regarded as clinically significant. b) Functional impairments in the course of the disease: - Day-to-day scores for functional impairments domain, - Overall (sum of all WURSS scores related to functional impairments over the follow-up). c) The need of symptomatic analgesics/antipyretics (average number of intakes) d) Evaluation of TAO1 safety: AEs and SAEs analysed in terms of frequency, severity, outcome and relationship to the study drug;Timepoint(s) of evaluation of this end point: Daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold	—

Measure

Time frame

Secondary end point(s): a) Duration of common cold: Duration is defined as the number of days from self-reported onset of disease to the last day before the participant answered “Not sick” to the question, “How sick do you feel today?”. A 2-day reduction in average disease duration versus placebo will be regarded as clinically significant. b) Functional impairments in the course of the disease: - Day-to-day scores for functional impairments domain, - Overall (sum of all WURSS scores related to functional impairments over the follow-up). c) The need of symptomatic analgesics/antipyretics (average number of intakes) d) Evaluation of TAO1 safety: AEs and SAEs analysed in terms of frequency, severity, outcome and relationship to the study drug;Timepoint(s) of evaluation of this end point: Daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold

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Countries

Belgium

Contacts

Public ContactClinical Operations

ECSOR sa/nv

luc.moriau@ecsor.com320477530807

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026