ClinicalTrials.gg
RecruitingNCT04528329Updated Sep 6, 2023

Anosmia and / or Ageusia and Early Corticosteroid Use

A Phase 4 interventional study of Early-Dexamethasone and Late dexamethazone in Covid19 and Anosmia, sponsored by ClinAmygate. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by ClinAmygate · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Covid19
  • Anosmia

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 300 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ClinAmygate is the lead sponsor of 18 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any case with COVID-19
  • Age more than or equal to 18 years
  • Mild to moderate severity

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Any for the interventional drug
  • Mentally disabled cases
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Early CS

    early use of dexamethasone as early as the laboratory confirmation of inflammation.

    Drug: Early-Dexamethasone

  • Active comparator
    Late CS

    Dexamethasone is to be used lately upon the deterioration of cases

    Drug: Late dexamethazone

Interventions

  • early use of dexamethasone as early as laboratory evidence of high inflammatory markers

    Also known as: Dexamethasone

  • Use of dexamethasone on deterioration of the cases with increased severity

    Also known as: Dexamethasone

06

What researchers measure

Primary outcomes

  1. Time to recovery

    Time to recovery from anosmia and / or agusia

    Time frame: one to 6 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04528329
Lead sponsor
ClinAmygate
Responsible party
Sponsor
First posted
Aug 27, 2020
Start date
Mar 30, 2021
Primary completion
Nov 1, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Sep 6, 2023

Study contacts

Emad R Issak, MD
Contact
dr.emad.r.h.issak@gmail.com
01272228989
Emad R Issak, MD
study director · Assalam Clinics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dexamethasone

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