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)

INTERVENTION: 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 placebo: Sublingual tablet Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] 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 and infestations ; MedDRA version: 14.1 Level: LLT Classification code 10046300 Term: Upper respiratory infection System Organ Class: 10021881 ‐ Infections and infestations PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults 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 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 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 SECONDARY OUTCOME: 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 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