Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
试验速览
- 阶段
- 不适用
- 发起方
- Respiralab
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of Loss of Smell in Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this study is to assess whether the use of a therapy combining olfactory training, corticoids, and phototherapy improves the PROMS compared to the use of olfactory training and corticosteroids only. To accomplish this goal the study will consist of 40 participants. The participants must present olfactory dysfunction for at least 4 weeks after a coronavirus-19 infection. Furthermore, to be eligible each participant will need a polymerase chain reaction test with positive results for coronavirus-19.
详细描述
Standard Operating Procedures: Patients attending consult and calls for follow-up.
Plan for missing data: Missing data will be managed with statistical tests.
Statistical analysis
Categorical variables, whenever dichotomous or nominal, will be reported as frequencies and percentages. Normality will be assessed by the Kolmogorov Smirnov test. Descriptive statistics will be reported as mean (standard deviation) or median (interquartile range). To analyze the correlation between quantitative variables, the parametric Pearson test or the nonparametric Spearman's test will be used, subjected to their distribution. Differences between Diffusing capacity for carbon monoxide groups will be analyzed for statistical significance by the chi-square test for categorical variables and by a two-sample t-test or Wilcoxon rank-sum test for continuous variables as applicable. Statistical significance will be set at a P-value less than 0.05. Analyses will be performed using Statistical Package for the Social Sciences (V. 22.0) software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will receive information about both treatments, but won't have knowledge about which treatment is applied.
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
- •Positive coronavirus polymerase chain reaction patients who experience loss of smell for more than 4 weeks after symptoms begin will be included in the study but at time of the trial with a negative result from a polymerase chain reaction.
- •Patients older than18 years.
排除标准
- •Patients younger than 18 years.
- •Pregnancy.
- •Patients who do not have a positive real-time polymerase chain reaction for Coronavirus
- •Patients who have contraindications for corticosteroid therapy such as:
- •Pregnant patients
- •Immunosuppressed
- •Patients with peptic ulcer
- •Patients with glaucoma
结局指标
主要结局
Change of Loss of Smell in Visual Analog Scale (VAS)
时间窗: It will be assessed through the study completion, an average of 15 weeks.
The Visual Analog Scale (VAS) scale is able to determine the grade of loss of smell. From 1 to 10, being 1 the minimum and 10 the maximum grade of loss of smell.
Changes in the Threshold Discrimination Identification (TDI) score
时间窗: It will be assessed through the study completion, an average of 15 weeks.
The Threshold Discrimination Identification score (TDI) is used when the patient undergoes olfactory training, it is comprised by 3 tests: the threshold, discrimination, and identification. Each result is interpreted according to 4 age groups. The test is accomplished by having the patient sniff at a felt pen which has been impregnated with 4ml of odorant fluid dissolved in propylene glycol. TDI scores defined functional anosmia as a TDI score \<16,5, normosmia as a TDI score \>30.5 and hyposmia as a score between these two values.
Changes of olfactory dysfunction in the Self-reported mini olfactory questionnaire (Self-MOQ)
时间窗: It will be assessed through the study completion, an average of 15 weeks.
The Self-reported mini olfactory questionnaire (Self-MOQ) is a simple, reliable and valid questionnaire to screen olfactory dysfunction in clinical practice. For the sample in the current study, the optimal scores will be 3.5, 4.5, and 3.5 for distinguishing normosmic from hyposmic/ anosmic patients, anosmic patients, and hyposmic patients, respectively.
次要结局
- Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)(It will be assessed through the study completion, an average of 15 weeks.)
研究者
Ivan Cherrez Ojeda
Research Professor of Allergy, Immunology and Pulmonology
Respiralab