Anosmia and / or Ageusia and Early Corticosteroid Use

Sponsor
ClinAmygate (Other)
Overall Status
Recruiting
CT.gov ID
NCT04528329
Collaborator
(none)
300
1
2
20.5
14.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early CS

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

Drug: Early-Dexamethasone
early use of dexamethasone as early as laboratory evidence of high inflammatory markers
Other Names:
  • Dexamethasone
  • Active Comparator: Late CS

    Dexamethasone is to be used lately upon the deterioration of cases

    Drug: Late dexamethazone
    Use of dexamethasone on deterioration of the cases with increased severity
    Other Names:
  • Dexamethasone
  • Outcome Measures

    Primary Outcome Measures

    1. Time to recovery [one to 6 weeks]

      Time to recovery from anosmia and / or agusia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • Diabetes

    • Any contra-indication for the interventional drug

    • Mentally disabled cases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asalam Maadi Cairo Egypt 11433

    Sponsors and Collaborators

    • ClinAmygate

    Investigators

    • Study Director: Emad R Issak, MD, Assalam Clinics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ClinAmygate
    ClinicalTrials.gov Identifier:
    NCT04528329
    Other Study ID Numbers:
    • PR0013
    First Posted:
    Aug 27, 2020
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022