Anosmia and / or Ageusia and Early Corticosteroid Use

NCT ID: NCT04528329

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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

Conditions

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Covid19 Anosmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early CS

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

Group Type EXPERIMENTAL

Early-Dexamethasone

Intervention Type DRUG

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

Late CS

Dexamethasone is to be used lately upon the deterioration of cases

Group Type ACTIVE_COMPARATOR

Late dexamethazone

Intervention Type DRUG

Use of dexamethasone on deterioration of the cases with increased severity

Interventions

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Early-Dexamethasone

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

Intervention Type DRUG

Late dexamethazone

Use of dexamethasone on deterioration of the cases with increased severity

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Dexamethasone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emad R Issak, MD

Role: STUDY_DIRECTOR

Assalam Clinics

Locations

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Asalam

Maadi, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Emad R Issak, MD

Role: CONTACT

01272228989

Facility Contacts

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Emad R Issak, MD

Role: primary

01272228989

References

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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.

Reference Type BACKGROUND
PMID: 24400953 (View on PubMed)

Other Identifiers

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PR0013

Identifier Type: -

Identifier Source: org_study_id

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