Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19

• Sponsor: Fayoum University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05148832
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 12.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Olfactory Dysfunction	Drug: Administration of Systemic Corticosteroid	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 67 Covid-19 patients with symptoms of ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR).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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: Aug 20, 2021
• Actual Study Completion Date: Nov 15, 2021

Arms and Interventions

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.	Drug: Administration of Systemic Corticosteroid; 10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery.

Outcome Measures

Primary Outcome Measures

1. Taste sensation [3 months]

   recovery of taste sensation by questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo		Egypt	21523

Sponsors and Collaborators

• Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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. Review. 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.

• Responsible Party: Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University
• ClinicalTrials.gov Identifier: NCT05148832
• Other Study ID Numbers: Taste COVID-19
• First Posted: Dec 8, 2021
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University: COVID-19; olfactory dysfunction; Gustatory dysfunction; Corticosteriods
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Dec 22, 2021