Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19

Respiralab

Status: Unknown

Conditions: Smell Disorders

Treatments: Combination Product: OT+Corticosteroids; Combination Product: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05177445

HCK-RNLTA-19-0007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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:

  1. Pregnant patients
  2. Immunosuppressed
  3. Patients with peptic ulcer
  4. Diabetics
  5. Patients with glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention group with phototherapy

Experimental group

Description:

Patients that present loss of smell 4 weeks after their coronavirus-19 infection and that have had a real-time polymerase chain reaction (reverse transcriptase polymerase chain reaction ) positive for coronavirus-19 will receive the phototherapy intervention. It consists of the introduction of the nasal probe of the phototherapy device in the nasal cavity of the patient. A mixture of ultraviolet light A, ultraviolet light B and red light will be applied between 2 and 3 minutes. The patient will receive a maximum of 10 interventions. Furthermore both oral corticosteroids (prednisone 40mg) and olfactory training will be applied, in the intervals of daily for 10 days and daily for the duration of the study respectively.

Treatment:

Combination Product: Phototherapy

Intervention group (corticosteroids + OT) without Phototherapy

Active Comparator group

Description:

Patients that present loss of smell 4 weeks after their coronavirus-19 infection and that have had a real-time polymerase chain reaction (reverse transcriptase polymerase chain reaction )and both oral corticosteroids (prednisone 40mg) and olfactory training will be applied, in the intervals of daily for 10 days and daily for the duration of the study respectively.

Treatment:

Combination Product: OT+Corticosteroids