Covid19Phase 4NCT04528329
Anosmia and / or Ageusia and Early Corticosteroid Use
A Phase 4 study testing Early-Dexamethasone and Late dexamethazone in people with Covid19 and Anosmia, run by ClinAmygate at 1 site in Egypt.
Trial summary
Time to recover of Anosmia and / or ageusia and early corticosteroid use Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Early-Dexamethasone and Late dexamethazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2021to 30 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any case with COVID-19
- Age more than or equal to 18 years
- Mild to moderate severity
Who cannot join
- Diabetes
- Any contra-indication for the interventional drug
- Mentally disabled cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Asalam
Maadi, Cairo Governorate, 11433
Emad R Issak, MD, 01272228989, dr.emad.r.h.issak@gmail.com
About this study
Official title: Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery
Time to recover of Anosmia and / or ageusia and early corticosteroid use
Read the detailed description
In a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. The apparent volume of distribution was 1 L/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. The bioavailability of oral dexamethasone was 81% (95% CI = 54-121%). However, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone.
Time to recover of Anosmia and / or ageusia and early corticosteroid use
- Being tested
- Early-Dexamethasone, Late dexamethazone
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early-DexamethasoneDrug
Also called Dexamethasone
early use of dexamethasone as early as laboratory evidence of high inflammatory markers
Late dexamethazoneDrug
Also called Dexamethasone
Use of dexamethasone on deterioration of the cases with increased severity
| Study group | Role | What they receive |
|---|---|---|
| Early CS | Experimental | early use of dexamethasone as early as the laboratory confirmation of inflammation. Receives: Drug: Early-Dexamethasone |
| Late CS | Active comparator | Dexamethasone is to be used lately upon the deterioration of cases Receives: Drug: Late dexamethazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery
Time to recovery from anosmia and / or agusia
Measured: one to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start30 Mar 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emad R Issak, MD, Study director, Assalam Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528329
- Sponsor's protocol ID
- PR0013
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
PubMed 24400953
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery
- ClinicalTrials.gov ID
- NCT04528329
- Acronym / sponsor ID
- PR0013
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Aug 2020 (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.
Time to recover of Anosmia and / or ageusia and early corticosteroid use
Detailed description
In a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. The apparent volume of distribution was 1 L/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. The bioavailability of oral dexamethasone was 81% (95% CI = 54-121%). However, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone.
Time to recover of Anosmia and / or ageusia and early corticosteroid use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early CS | Experimental | Drug: Early-Dexamethasoneearly use of dexamethasone as early as the laboratory confirmation of inflammation. |
| Late CS | Active comparator | Drug: Late dexamethazoneDexamethasone is to be used lately upon the deterioration of cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any case with COVID-19
- Age more than or equal to 18 years
- Mild to moderate severity
Key exclusion criteria (3 listed)
- Diabetes
- Any contra-indication for the interventional drug
- Mentally disabled cases
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 |
|---|---|---|
| Early-DexamethasoneAlso: Dexamethasoneearly use of dexamethasone as early as laboratory evidence of high inflammatory markers | Drug | Early CS |
| Late dexamethazoneAlso: DexamethasoneUse of dexamethasone on deterioration of the cases with increased severity | Drug | Late CS |
Primary outcome
Time to recovery
Time frame: one to 6 weeks
Time to recovery from anosmia and / or agusia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 24400953Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
- 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.
Emad R Issak, MD study director
Assalam Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early-Dexamethasone and Late dexamethazone in people with Covid19 and Anosmia, run by ClinAmygate 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emad R Issak, MD (01272228989, dr.emad.r.h.issak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: one to 6 weeks). 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 NCT04528329, which also lists 1 linked publication.
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 6 Sep 2023.