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Anosmia and / or Ageusia and Early Corticosteroid Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528329
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ClinAmygate

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: Time to Recover of Anosmia and / or Ageusia and Early Corticosteroid Use
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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


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

Locations
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Egypt
Asalam Recruiting
Maadi, Cairo, Egypt, 11433
Contact: Emad R Issak, MD    01272228989    dr.emad.r.h.issak@gmail.com   
Sponsors and Collaborators
ClinAmygate
Investigators
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Study Director: Emad R Issak, MD Assalam Clinics
Publications:
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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: September 16, 2020
Last Verified: September 2020
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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Olfaction Disorders
Ageusia
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Taste Disorders
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action