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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 33
- 主要终点
- Severity of symptoms of common cold
研究概览
简要总结
The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections
详细描述
TAO1 is an investigational medicinal product containing homoeopathic dilutions (<10-24M) of antibodies purified from the serum of rabbit immunised against a synthetic peptide with an amino acid sequence selected in the human toll-like receptor type 3 sequence (anti-TLR3). It is intended for the treatment of viral Upper Respiratory Tract Infections (URTIs) such as common cold, influenza or influenza-like illnesses.
The validity of the TAO1 development approach was addressed in a proof of concept study of efficacy in a non-lethal influenza infection in mice. In this blinded study, TAO1 was given in drinking water for 5 days before and 10 days after viral challenge. The statistical analysis of preclinical data was carried out by using the Mann-Whitney non-parametric test (2-tailed). The clinical disease duration was significantly reduced from 6.0 (5.25 (25th percentile);7.0 (75th percentile)) days to 5.0 (5.0;5.0) days (p=0.00037) as well as the overall disease severity that was lowered from 8.0 (7.0;10.0) points to 6.0 (5.0;7.5) points (p=0.00032).
Given the high homoeopathic dilution, the active substance in the finished product lies beyond sensitivity of existing analytical assays. TAO1 is therefore not amenable to pharmacokinetics studies.
There are currently no data on clinical efficacy of TAO1 in common cold obtained in double-blind placebo-controlled clinical trials. Based on the efficacy in the animal model, the expected magnitude of effect of TAO1 in humans is a reduction of common cold duration by 2-3 days, provided that the treatment is started early after the onset of the symptoms.
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged > or = 18 years
- •Ability and willingness to adhere to the study protocol
- •Signed informed consent
- •Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?"
- •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.
排除标准
- •Specific chronic diseases (autoimmune disease, chronic bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)
- •Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
- •Cancer therapy
- •Immunosuppressant therapies
- •Use of systemic corticosteroids
- •A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)
- •Any of the common cold symptoms persisting since more than 36 hours
- •Use of other homeopathic drugs designed to treat URTIs
- •Use of antibiotics, anti-histaminergic drugs or decongestants
- •Participation in another clinical trial within one month prior to treatment start
- •Previous participation (receipt of randomised treatment) in this study
研究组 & 干预措施
TAO1, oral homeopathic antibodies
TAO1 is an investigational medicinal product containing homeopathic dilutions (<10-24M) of antibodies purified from the serum of rabbit immunised against a synthetic peptide with an amino acid sequence selected in the human toll-like receptor type 3 sequence (anti-TLR3). It is intended for the treatment of viral Upper Respiratory Tract Infections (URTIs) such as common cold, influenza or influenza-like illnesses.
干预措施: TAO1, oral homeopathic antibodies (Drug)
Placebo
Same characteristics as investigational medicinal Product except for homeopathic dilutions of oral antibodies to the TLR3 FYW peptide
干预措施: TAO1, oral homeopathic antibodies (Drug)
结局指标
主要结局
Severity of symptoms of common cold
时间窗: Since start of symptoms of common cold up to the visit 3 (day 10-14)
Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (sum of all WURSS scores over the follow-up). The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) is a validated tool to evaluate the duration and severity of common cold. It is constituted of twenty-one categorical questions (Likert-type 7-level severity scale).
次要结局
- Duration of common cold(Since start of symptoms of common cold up to visit 3 (Day 10-14))
- Functional impairments in the course of the disease(Since start of symptoms of common cold up to visit 3 (Day 10-14))
- The need of symptomatic analgesics/antipyretics(Since start of symptoms of common cold up to visit 3 (Day 10-14))
- Evaluation of safety(since start of symptoms of common cold up to visit 3 (Day 10-14))