Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up

ClinAmygate

Status and phase: Active, not recruiting; Phase 4

Conditions: Covid19; Corticosteroids

Treatments: Drug: Early-Corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT04530409

PR0012

Details and patient eligibility

About

Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Full description

The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.

The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.

Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any case with COVID-19 more than or equal to 18 years
• mild and moderate severity

Exclusion criteria

• Severe to critical COVID-19
• 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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752 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-Corticosteroids

Late CS

No Intervention group

Description:

Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 \< 92%