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Clinical Trials/NCT04530409
NCT04530409
Active, not recruiting
Phase 4

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

ClinAmygate1 site in 1 country752 target enrollmentMarch 20, 2021

Overview

Phase
Phase 4
Intervention
Early-Corticosteroids
Conditions
Covid19
Sponsor
ClinAmygate
Enrollment
752
Locations
1
Primary Endpoint
Percentage of cases that will need oxygen supplementation
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2021
End Date
October 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ClinAmygate
Responsible Party
Principal Investigator
Principal Investigator

Emad R Issak

Dr

ClinAmygate

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

Arms & Interventions

Early CS

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

Intervention: Early-Corticosteroids

Outcomes

Primary Outcomes

Percentage of cases that will need oxygen supplementation

Time Frame: 10 days

Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%

Percentage of cases that will need hospitalization

Time Frame: 10 days

Deterioration in the clinical picture of cases that necessitate hospitalization

28-days mortality

Time Frame: 28 days

Percentage of cases who died within 28 days of presentation

Secondary Outcomes

  • Percentage of cases with increased d-dimer(10 days)
  • Percentages of COVID-19 Severity according to CDC 2020(10 days)
  • Time to return to daily activity(60 days)
  • Percentage reduction in LDH(10 days)
  • Percentage reduction in CRP(10 days)
  • Percentage reduction in Ferritin(10 days)

Study Sites (1)

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