Corticosteroid Nasal Spray in COVID-19 Anosmia
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|ClinicalTrials.gov Identifier: NCT04484493|
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Anosmia||Drug: mometasone furoate nasal spray||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
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
|Benha University Hospital, Faculty of Medicine|
|Banhā, Qalubia, Egypt, 13512|
|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|