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

Phase 4

Active, not recruiting

• Conditions: Covid19; Corticosteroids
• Interventions: Drug: Early-Corticosteroids

• Registration Number: NCT04530409
• Lead Sponsor: ClinAmygate

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.

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Study Start: 2021-03-20
• Primary Completion: 2021-11-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 752

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early CS	Early-Corticosteroids	early use of dexamethasone as early as the laboratory confirmation of inflammation.

Primary Outcome Measures

Name	Time	Method
Percentage of cases that will need oxygen supplementation	10 days	Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
Percentage of cases that will need hospitalization	10 days	Deterioration in the clinical picture of cases that necessitate hospitalization
28-days mortality	28 days	Percentage of cases who died within 28 days of presentation

Secondary Outcome Measures

Name	Time	Method
Percentage of cases with increased d-dimer	10 days	Percentage of cases with increased d-dimer from baseline
Percentages of COVID-19 Severity according to CDC 2020	10 days	Percentages of COVID-19 severity according to CDC 2020
Time to return to daily activity	60 days	Time to return to daily activity level
Percentage reduction in LDH	10 days	Percentage reduction in LDH from baseline
Percentage reduction in CRP	10 days	Percentage reduction in CRP from baseline
Percentage reduction in Ferritin	10 days	Percentage reduction in Ferritin from baseline

Trial Locations

Locations (1)

Asalam; 🇪🇬 Maadi, Cairo, Egypt