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Completed

NCT Number: NCT04484493

Corticosteroid Nasal Spray in COVID-19 Anosmia

The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.

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Key information

About this study

This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples.

Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.

As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults 18 yrs or older patients
  • confirmed case (+ve PCR),
  • recovered/discharged (2 -ve PCR),
  • suffered from sudden recent anosmia or hyposmia

Exclusion criteria

  • patients already on nasal steroid
  • with previous chronic rhinological pathologies,
  • patients on systemic steroid for previous systemic disease,
  • anosmia improved before COVID19 recovery,
  • pregnancy
  • patients who will not complete the follow up period.

Treatment and study plan

Mometasone Furoate Nasal spray

Drug

dose of 2 puff in each nostril (100 µg once daily each nostril).

Other names: steroid nasal spray

Primary outcomes

  1. improvement of olfaction

    Time frame: 3 weeks

    The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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