Clinical trial NCT05177445: Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Official title: Efficacy and Safety of Phototherapy in the Treatment of Loss of Smell Post Acute Infection of Coronavirus 19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smell Disorders
Keywords: Anosmia
Hyposmia
Coronavirus
Smell Disorders
Phototherapy
Lead sponsor: Respiralab
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Interventional study, single blinded, convenience sampling.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Loss of Smell in Visual Analog Scale (VAS)
timeFrame: It will be assessed through the study completion, an average of 15 weeks.
measure: Changes in the Threshold Discrimination Identification (TDI) score
timeFrame: It will be assessed through the study completion, an average of 15 weeks.
measure: Changes of olfactory dysfunction in the Self-reported mini olfactory questionnaire (Self-MOQ)
timeFrame: It will be assessed through the study completion, an average of 15 weeks.
Secondary outcomes:
measure: Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)
timeFrame: It will be assessed through the study completion, an average of 15 weeks.
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Respiralab Research Group
state: Guayas
Study officials:
affiliation: RESPIRALAB RESEARCH GROUP
name: Manuel I Cherrez Ojeda, MD. MsC.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cingi C, Yaz A, Cakli H, Ozudogru E, Kecik C, Bal C. The effects of phototherapy on quality of life in allergic rhinitis cases. Eur Arch Otorhinolaryngol. 2009 Dec;266(12):1903-8. doi: 10.1007/s00405-009-1048-y. Epub 2009 Jul 22.
citation: Beissert S, Schwarz T. Role of immunomodulation in diseases responsive to phototherapy. Methods. 2002 Sep;28(1):138-44. doi: 10.1016/s1046-2023(02)00217-7.
citation: Matz H. UV light and its interaction with cutaneous receptors. Dermatol Clin. 2007 Oct;25(4):633-41, x. doi: 10.1016/j.det.2007.06.006.
citation: Le Bon SD, Konopnicki D, Pisarski N, Prunier L, Lechien JR, Horoi M. Efficacy and safety of oral corticosteroids and olfactory training in the management of COVID-19-related loss of smell. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):3113-3117. doi: 10.1007/s00405-020-06520-8. Epub 2021 Jan 9.
citation: Brehmer D. Endonasal phototherapy with Rhinolight for the treatment of allergic rhinitis. Expert Rev Med Devices. 2010 Jan;7(1):21-6. doi: 10.1586/erd.09.56.
citation: Novak Z, Berces A, Ronto G, Pallinger E, Dobozy A, Kemeny L. Efficacy of different UV-emitting light sources in the induction of T-cell apoptosis. Photochem Photobiol. 2004 May;79(5):434-9. doi: 10.1562/ra-003r.1.
citation: O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2021 Jul 22;7(7):CD013876. doi: 10.1002/14651858.CD013876.pub2.