Anosmia and / or Ageusia and Early Corticosteroid Use

ClinAmygate

Status and phase: Enrolling; Phase 4

Conditions: Anosmia; Covid19

Treatments: Drug: Early-Dexamethasone; Drug: Late dexamethazone

Study type: Interventional

Funder types: Other

Identifiers

NCT04528329

PR0013

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Early CS

Experimental group

Description:

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

Treatment:

Drug: Early-Dexamethasone

Late CS

Active Comparator group

Description:

Dexamethasone is to be used lately upon the deterioration of cases

Treatment:

Drug: Late dexamethazone