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

December 14, 2021 updated by: Ivan Cherrez Ojeda, Respiralab
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090512
        • Respiralab Research Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuel I Cherrez Ojeda, MD. MsC.
        • Sub-Investigator:
          • Karla I Robles Velasco, MD.
        • Sub-Investigator:
          • Maria J Farfan Bajaña, Bachelor
        • Sub-Investigator:
          • Matias Panchana Lascano, Bachelor
        • Sub-Investigator:
          • Christian A Rodriguez Holguin, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group with phototherapy
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.
Combination product: Phototherapy

Prior to the beginning of the procedure the patient will be administered a nasal decongestant. Second to this, the patient will be advised to blow his/her nose. This step allows the physician a better view and allows the light exposure to reach the majority of the nasal mucosa(9).

To start the intervention the physician will introduce the phototherapy device inside the patient's nasal cavity as the patient sits in an upright condition. As the procedure is ongoing the physician will slightly rotate the device in order to minimize dryness and to irradiate all the nasal cavity. After the intervention the patient will be administered an emollient/moisturizing drug to further hydrate the nasal mucosa(9).

The intervention will have a crescent duration, the first one will be only two minutes and the following ones will increase 15 seconds each until a plateau is reached at 3 minutes in the 5th intervention.

Other Names:
  • Corticosteroids
  • Olfactory training
Active Comparator: Intervention group (corticosteroids + OT) without Phototherapy
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.
Combination product: OT+Corticosteroids
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.
Other Names:
  • Corticosteroid
  • Olfactory training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Loss of Smell in Visual Analog Scale (VAS)
Time Frame: 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.
It will be assessed through the study completion, an average of 15 weeks.
Changes in the Threshold Discrimination Identification (TDI) score
Time Frame: 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.
It will be assessed through the study completion, an average of 15 weeks.
Changes of olfactory dysfunction in the Self-reported mini olfactory questionnaire (Self-MOQ)
Time Frame: 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.
It will be assessed through the study completion, an average of 15 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Anxiety and depression in the Hospital Anxiety and Depression Scale(HADS)
Time Frame: It will be assessed through the study completion, an average of 15 weeks.

The Hospital Anxiety and Depression Scale (HADS) allows for the assessment of both anxiety and depression as it has been seen that both can be present at the same time. This scale focuses on non-physical symptoms so that it can be used to diagnose depression in people with significant physical illness.

The questionnaire comprises seven questions for both anxiety and depression, and should take around 2-5min to complete. A score between 8 and 10 is considered as mild, if it is between 11 and 14 it is considered moderate and if it exceeds 15 it is considered severe.
It will be assessed through the study completion, an average of 15 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respiralab

Investigators

  • Principal Investigator: Manuel I Cherrez Ojeda, MD. MsC., Respiralab Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCK-RNLTA-19-0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smell Disorders

Clinical Trials on Phototherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe