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Anosmia and / or Ageusia and Early Corticosteroid Use

Primary Purpose

Covid19, Anosmia

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Early-Dexamethasone

Late dexamethazone

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early CS

Late CS

Arm Description

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

Dexamethasone is to be used lately upon the deterioration of cases

Outcomes

Primary Outcome Measures

Time to recovery

Time to recovery from anosmia and / or agusia

Secondary Outcome Measures

Full Information

NCT ID

NCT04528329

First Posted

August 24, 2020

Last Updated

September 4, 2023

Sponsor

ClinAmygate

1. Study Identification

Unique Protocol Identification Number

NCT04528329

Brief Title

Anosmia and / or Ageusia and Early Corticosteroid Use

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ClinAmygate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Anosmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early CS

Arm Type

Experimental

Arm Description

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

Arm Title

Late CS

Arm Type

Active Comparator

Arm Description

Dexamethasone is to be used lately upon the deterioration of cases

Intervention Type

Drug

Intervention Name(s)

Early-Dexamethasone

Other Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Late dexamethazone

Other Intervention Name(s)

Dexamethasone

Intervention Description

Use of dexamethasone on deterioration of the cases with increased severity

Primary Outcome Measure Information:

Title

Time to recovery

Description

Time to recovery from anosmia and / or agusia

Time Frame

one to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emad R Issak, MD

Phone

01272228989

dr.emad.r.h.issak@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad R Issak, MD

Organizational Affiliation

Assalam Clinics

Official's Role

Study Director

Facility Information:

Facility Name

Asalam

City

Maadi

State/Province

Cairo

ZIP/Postal Code

11433

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emad R Issak, MD

Phone

01272228989

dr.emad.r.h.issak@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24400953

Citation

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.

Results Reference

background

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Anosmia and / or Ageusia and Early Corticosteroid Use

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