A Randomized, Multicentrique, Single-Blind, Observational Pilot Study To Evaluate Efficacy And Safety Of Pirdal Nasal Spray In Preventing Symptomatic Manifestation Of Disease In Covid-19 Proven Cases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VITROBIO SAS
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1 To assess the change in the intensity of clinical symptoms (Nasal, general, coughing and respiratory) as per the Daily Questionnaire filled directly by the patients according to their randomization number
研究概览
简要总结
Clinical trial results in control (ST) patients receiving standard treatments showed a strong aggravation of the mean respiratory symptoms Leicester Cough Questionnaire (LCQ) and Visual analogue scale (VAS) parameters on days 1 and 2 followed by further slow deterioration up to day 4-6 and progressive improvement thereafter. In the test product group (TP, PIRDAL or Covispray),
treated with osmotic polymeric nasal film, the respiratory symptoms did not aggravate on days 1 and 2 but remained stable up to day 5 followed by slow improvement, parallel to the ST group, up to day 14. The mean LCQ and VAS score difference between the TP and the ST groups was statistically significant (p<0.05) from day 1 onwards. The reason for this stabilization of respiratory
symptoms immediately after the first treatment probably resides in the fact that the TP acts instantly by cleaning newly generated virus particles as well as inflammatory cytokines towards the film where they are trapped and inactivated by polymers. This mechanical cleaning minimizes cellular destruction and stimulates reconstruction of nasal mucosa. TP cleans only the free-floating nasal surface virus and protein molecules but has no effect on the intracellular and circulating virus particles which continue pouring onto the nasal surface and maintaining the infection for a few weeks. This explains why there is a sharp drop of Covid-19 clinical symptoms during the first 4-6 days, but further improvement is progressive and slow. The TP does not cure the disease but
strongly reduces clinical symptoms right after the 1 st treatment. This approach minimizes the probability of developing severe respiratory symptoms. The intensity of fever, loss of sense of taste, small, and headache were also reduced in the TP compared to ST group right after the start of 1 st treatment.
Being a mechanically acting, non-specific nasal surface cleaner, the test product
should act against any Covid-19 viral mutant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male or Female patients detected positive for Covid 19 by RT-PCR test and who have no or slight nasal /respiratory clinical signs at the time of recruitment.
- •2 The patients aged between 18-70 at the time of screening.
- •3 Patients who agreed not to self- medicate with other potential preventive ARI-antivirals.
- •ï‚· Not currently symptomatic with an acute respiratory illness 4 Patients with Cooperative and understanding skills.
- •5 Patient willing to provide written informed consent.
- •6 Patient able to have internet access each day of the study to complete the online questionnaire 7 Patients ready to abstain from using any drug other than Investigational Product for the treatment of the studied condition, except in emergencies, in which case the responsible party must be immediately notified.
- •Patients with moderate hypertension or diabetes may be included in the study.
排除标准
- •Patients, who will meet any of the exclusion criteria, will not be included in the study.
- •1 Hypersensitivity/History of allergy to any of the investigational products componants 2 Any recent nasal surgery 3 Abnormal structural narrowing of sinus passages such as Deviated Nasal Septum or other kind of anatomical obstruction 4 Any unstable, serious co-existing medical condition including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit 5 Clinical evidence of immunosuppression 6 Patient under treatment of viral disease 7 Patient with severe respiratory signs 8 Patients +ve for serum antibodies 9 Patients who have participated in other clinical studies less than 1 year prior to screening.
结局指标
主要结局
1 To assess the change in the intensity of clinical symptoms (Nasal, general, coughing and respiratory) as per the Daily Questionnaire filled directly by the patients according to their randomization number
时间窗: From baseline to post randomization visit on days 7 and 14.
2 The following symptoms will be scored for each patient:
时间窗: From baseline to post randomization visit on days 7 and 14.
General: Fever, change in smell, taste appreciation, headache loss of taste, Nasal, Respiratory, Digestive
时间窗: From baseline to post randomization visit on days 7 and 14.
3 To assess the number of patients in each group developing minor or severe clinical signs
时间窗: From baseline to post randomization visit on days 7 and 14.
次要结局
- To assess the impact of PIRDAL spray on the quality of life of patients using Quality of life Questionnaire (EQ-5D-3L).(From baseline to post randomization visit on days 7 and 14.)
- Percentage of the patients reporting adverse events.(From baseline to post randomization visit on days 7 to 14.)