- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148832
Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
December 7, 2021 updated by: Alshaimaa Ahmed shabaan, Fayoum University
Association Between Administration of Systemic Corticosteroids and the Recovery of Olfactory and/or Gustatory Functions in Patients With COVID-19: A Prospective Cohort Study
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
80
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 Locations
-
-
-
Cairo, Egypt, 21523
- Faculty of Dentistry
-
-
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
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cortocosteroid
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.
|
10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taste sensation
Time Frame: 3 months
|
recovery of taste sensation by questionnaire
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
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 (Actual)
May 1, 2021
Primary Completion (Actual)
August 20, 2021
Study Completion (Actual)
November 15, 2021
Study Registration Dates
First Submitted
December 5, 2021
First Submitted That Met QC Criteria
December 5, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
December 22, 2021
Last Update Submitted That Met QC Criteria
December 7, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Taste COVID-19
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
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.