COVID-19NCT05148832
Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19
A study testing Administration of Systemic Corticosteroid in people with COVID-19 and Olfactory Dysfunction, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, Olfactory Dysfunction
- What is being tested?
- Administration of Systemic Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- COVID-19, Olfactory Dysfunction
- Being tested
- Administration of Systemic Corticosteroid
- Keywords
- COVID-19, olfactory dysfunction, Gustatory dysfunction, Corticosteriods
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Systemic CorticosteroidDrug
10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery.
| Study group | Role | What they receive |
|---|---|---|
| Cortocosteroid | Experimental | 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. Receives: Drug: Administration of Systemic Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste sensation
recovery of taste sensation by questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 May 2021
- Primary completion20 Aug 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148832
- Sponsor's protocol ID
- Taste COVID-19
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33024307Vaira 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.
PubMed 32342566
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05148832
- Acronym / sponsor ID
- Taste COVID-19
- Conditions
- COVID-19, Olfactory Dysfunction
- Keywords
- COVID-19, olfactory dysfunction, Gustatory dysfunction, Corticosteriods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 67 Covid-19 patients with symptoms of ageusia and anosmia were recruited (that their covid infection was confirmed by using PCR).
| Arm | Type | Receives |
|---|---|---|
| Cortocosteroid | Experimental | Drug: Administration of Systemic Corticosteroidageusia 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of Systemic Corticosteroid10 mg of systemic corticosteroids were prescribed weekly to patients to observe taste and smell sensation recovery. | Drug | Cortocosteroid |
Primary outcome
Taste sensation
Time frame: 3 months
recovery of taste sensation by questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Background: PubMed 33024307Hu 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.
- Background: PubMed 32342566Vaira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of Systemic Corticosteroid in people with COVID-19 and Olfactory Dysfunction, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste sensation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.