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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

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

Browse trials for

03

Who can participate

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

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 contra-indication for the interventional drug
  • Mentally disabled cases
04

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

  • DrugEarly-Dexamethasone

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

    Also known as: Dexamethasone

  • DrugLate dexamethazone

    Use of dexamethasone on deterioration of the cases with increased severity

    Also known as: Dexamethasone

05

What researchers measure

Primary outcomes

  1. Time to recovery

    Time to recovery from anosmia and / or agusia

    Time frame: one to 6 weeks

06

Study locations

1 of 1 sites recruiting
07

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

08

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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