Anosmia and / or Ageusia and Early Corticosteroid Use

September 4, 2023 updated by: ClinAmygate

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: one to 6 weeks
Time to recovery from anosmia and / or agusia
one to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinAmygate

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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