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NCT04528329 Clinical Trial

Anosmia and / or Ageusia and Early Corticosteroid Use

Covid19 Clinical Trial

Official title:
Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04528329
Other study ID # PR0013
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 30, 2021
Est. completion date December 30, 2023

Study information
Verified date September 2023
Source ClinAmygate
Contact Emad R Issak, MD
Phone 01272228989
Email dr.emad.r.h.issak@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Time to recover of Anosmia and / or ageusia and early corticosteroid use

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 30, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any case with COVID-19 - Age more than or equal to 18 years - Mild to moderate severity Exclusion Criteria: - Diabetes - Any contra-indication for the interventional drug - Mentally disabled cases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Early-Dexamethasone
early use of dexamethasone as early as laboratory evidence of high inflammatory markers
• Late dexamethazone
Use of dexamethasone on deterioration of the cases with increased severity

Locations
Country Name City State
Egypt Asalam Maadi Cairo

Sponsors (1)
Lead Sponsor Collaborator
ClinAmygate

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to recovery Time to recovery from anosmia and / or agusia one to 6 weeks
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