NCT04528329

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_4 covid19

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

August 24, 2020

Last Update Submit

September 4, 2023

Conditions

Covid19Anosmia

Outcome Measures

Primary Outcomes (1)

  • Time to recovery

    Time to recovery from anosmia and / or agusia

    one to 6 weeks

Study Arms (2)

Early CS

EXPERIMENTAL

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

Drug: Early-Dexamethasone

Late CS

ACTIVE COMPARATOR

Dexamethasone is to be used lately upon the deterioration of cases

Drug: Late dexamethazone

Interventions

Early-DexamethasoneDRUG

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

Also known as: Dexamethasone
Early CS
Late dexamethazoneDRUG

Use of dexamethasone on deterioration of the cases with increased severity

Also known as: Dexamethasone
Late CS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any case with COVID-19
  • Age more than or equal to 18 years
  • Mild to moderate severity

You may not qualify if:

  • Diabetes
  • Any contra-indication for the interventional drug
  • Mentally disabled cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asalam

Maadi, Cairo Governorate, 11433, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24400953BACKGROUND

MeSH Terms

Conditions

COVID-19Anosmia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Emad R Issak, MD

    Assalam Clinics

    STUDY DIRECTOR

Central Study Contacts

Emad R Issak, MD

CONTACT

01272228989dr.emad.r.h.issak@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

March 30, 2021

Primary Completion

November 1, 2023

Study Completion

December 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)