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

NCT ID: NCT04530409

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 752 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-20
• Study Completion Date: 2023-10-15

Brief Summary

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

Detailed 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.

Conditions

Covid19; Corticosteroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early CS

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

Group Type: EXPERIMENTAL

Early-Corticosteroids

Intervention Type: DRUG

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

Late CS

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early-Corticosteroids

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

Intervention Type: DRUG

Other Intervention Names

Dexamethasone; Methylprednisolone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAmygate

OTHER

Sponsor Role: lead

Responsible Party

Emad R Issak

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emad R Issak

Role: PRINCIPAL_INVESTIGATOR

Assalam Clinics

Locations

Asalam

Maadi, Cairo Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24400953 (View on PubMed)

Other Identifiers

PR0012

Identifier Type: -

Identifier Source: org_study_id