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Anosmia and / or Ageusia and Early Corticosteroid Use

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ClinicalTrials.gov Identifier: NCT04528329
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : November 1, 2022
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Covid19 Anosmia Drug: Early-Dexamethasone Drug: Late dexamethazone 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 30, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : February 15, 2023

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 Name: 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 Name: Dexamethasone

Primary Outcome Measures :
  1. Time to recovery [ Time Frame: one to 6 weeks ]
    Time to recovery from anosmia and / or agusia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528329

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Contact: Emad R Issak, MD 01272228989 dr.emad.r.h.issak@gmail.com

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Asalam Recruiting
Maadi, Cairo, Egypt, 11433
Contact: Emad R Issak, MD    01272228989    dr.emad.r.h.issak@gmail.com   
Sponsors and Collaborators
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Study Director: Emad R Issak, MD Assalam Clinics
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Responsible Party: ClinAmygate
ClinicalTrials.gov Identifier: NCT04528329    
Other Study ID Numbers: PR0013
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Taste Disorders
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents