ACTRN12621000604808已完成3 期
Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as a symptomatic treatment for early stage common cold in the natural setting.
Firebrick Pharma Limited0 个研究点目标入组 502 人开始时间: 2021年5月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 502
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Access to a smartphone or tablet to run the webapp (for electronic diary)
- •- Subject must respond affirmatively to the question: Do you think you have a cold?”
- •- Subject must have a runny nose and must report at least two of the other 7 Jackson symptoms – sneezing, sore throat, nasal congestion, cough, feeling unwell, chills, headache – plus a ‘moderate’ or ‘severe’ (i.e., not ‘mild’) score on at least one of the Jackson symptoms (including runny nose, but excluding sneezing) with a total Jackson score of at least 6.
- •- Cold symptoms started less than 36 hours prior to enrolment with a known time and date of symptom onset, which must be recorded
排除标准
- •- Positive result on a SARS-CoV-2 Rapid Antigen Test
- •- Fever >38°C; actual temperature will be recorded during screening
- •- Known iodine sensitivity
- •- Known thyroid disease
- •- Pregnant or nursing (breast-feeding)
- •- Intending to use during the study, any other nasal spray or any OTC cold medication that could influence study results (antihistamines, decongestants, combination cough/cold medications); paracetamol will be available as a rescue medication for any disabling symptoms; concomitant medications will be recorded
- •- Intending to use a povidone-iodine gargle during the study
- •- Any condition or consideration deemed by the Medical Officer (MO) to interfere with assessments or represent a risk to compliance; this will be assessed by a limited PE (physical exam) and nasal exam during screening
- •- Unwilling to sign the informed consent form (PICF)
- •- Anyone deemed to be a high-risk COVID-19 including the elderly, those with chronic diseases such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer, and anyone who is unvaccinated for COVID-19.
- •- Any vaccination may lead to cold/flu-like symptoms, so any subjects who have received a vaccine in the week prior to enrolment will be excluded from the trial. Similarly, anyone scheduled to or intending to be vaccinated (flu or COVID) during the 14-day period of the trial will be excluded. In all cases, trial personnel will encourage participants to get the COVID vaccine or continue with COVID vaccine boosters after the trial is completed.
研究者
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