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Corticosteroid Nasal Spray in COVID-19 Anosmia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484493
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Ahmed Abdelalim, Benha University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Anosmia Drug: mometasone furoate nasal spray Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
Actual Study Start Date : August 8, 2020
Actual Primary Completion Date : October 25, 2020
Actual Study Completion Date : November 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: mometasone nasal spray
Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.
Drug: mometasone furoate nasal spray
dose of 2 puff in each nostril (100 µg once daily each nostril).
Other Name: steroid nasal spray

No Intervention: control
Patients will not receive topical corticosteroid nasal spray but only olfactory training.



Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484493


Locations
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Egypt
Benha University Hospital, Faculty of Medicine
Banhā, Qalubia, Egypt, 13512
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Abdelrahman A Abdelalim, MD Benha Faculty of Medicine
Study Chair: Rasha A Elsayed, MD Benha Faculty of Medicine
Study Chair: Mona A Elawady, MD Benha Faculty of Medicine
Study Chair: Abdelhakim F Ghallab, MD Benha Faculty of Medicine
Study Chair: Ayman A Mohamady, MD Benha Faculty of Medicine
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abdelrahman Ahmed Abdelalim, MD lecturer, Benha University
ClinicalTrials.gov Identifier: NCT04484493    
Other Study ID Numbers: RC 4-7-2020
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdelrahman Ahmed Abdelalim, Benha University:
covid19
anosmia
mometasone nasal spray
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents