Back to resultsAdministration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
Primary Purpose
COVID-19, Olfactory Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Administration of Systemic Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, olfactory dysfunction, Gustatory dysfunction, Corticosteriods
Eligibility Criteria
Inclusion Criteria:
- all signs and symptoms were recorded included fever >38 °C, fatigue, myalgia, arthralgia, sore throat, headache, and its localization (diffuse, frontal, other localization), rhinorrhea, nasal obstruction, epistaxis, tinnitus, and hearing loss, sneezing, cough, sputum production, hemoptysis, dyspnea, respiratory rate >22, crackling sounds during auscultation, nausea, vomiting, diarrhea, and abdominal pain.
Exclusion Criteria:
- patients with absolute contraindications for systemic corticosteroids administration, pregnant women, smokers, and patients with any systemic disease or taking any medications that cause loss of taste or smell were excluded from this study.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cortocosteroid
Arm Description
ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR). 10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery. All data were recorded and then analyzed.
Outcomes
Primary Outcome Measures
Taste sensation
recovery of taste sensation by questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05148832
Brief Title
Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
Official Title
Association Between Administration of Systemic Corticosteroids and the Recovery of Olfactory and/or Gustatory Functions in Patients With COVID-19: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a family of viruses that usually affect animals. They also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia
Detailed Description
Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a family of viruses that usually affect animals. They also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia Smell and taste dysfunction is more frequent in the initial stages of covid-19 infection that occur within the first five days and may be used as pivotal symptoms in the early diagnosis of the disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Olfactory Dysfunction
Keywords
COVID-19, olfactory dysfunction, Gustatory dysfunction, Corticosteriods
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
67 Covid-19 patients with symptoms of ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR).
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cortocosteroid
Arm Type
Experimental
Arm Description
ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR). 10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery. All data were recorded and then analyzed.
Intervention Type
Drug
Intervention Name(s)
Administration of Systemic Corticosteroid
Intervention Description
10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery.
Primary Outcome Measure Information:
Title
Taste sensation
Description
recovery of taste sensation by questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all signs and symptoms were recorded included fever >38 °C, fatigue, myalgia, arthralgia, sore throat, headache, and its localization (diffuse, frontal, other localization), rhinorrhea, nasal obstruction, epistaxis, tinnitus, and hearing loss, sneezing, cough, sputum production, hemoptysis, dyspnea, respiratory rate >22, crackling sounds during auscultation, nausea, vomiting, diarrhea, and abdominal pain.
Exclusion Criteria:
patients with absolute contraindications for systemic corticosteroids administration, pregnant women, smokers, and patients with any systemic disease or taking any medications that cause loss of taste or smell were excluded from this study.
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
21523
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33024307
Citation
Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6. Erratum In: Nat Rev Microbiol. 2022 May;20(5):315.
Results Reference
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PubMed Identifier
32342566
Citation
Vaira LA, Deiana G, Fois AG, Pirina P, Madeddu G, De Vito A, Babudieri S, Petrocelli M, Serra A, Bussu F, Ligas E, Salzano G, De Riu G. Objective evaluation of anosmia and ageusia in COVID-19 patients: Single-center experience on 72 cases. Head Neck. 2020 Jun;42(6):1252-1258. doi: 10.1002/hed.26204. Epub 2020 Apr 29.
Results Reference
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Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
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