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

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

Detailed Description
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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.

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

Conditions
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Covid19, Corticosteroids

Intervention / Treatment
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* Drug: Early-Corticosteroids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early CS<br>early use of dexamethasone as early as the laboratory confirmation of inflammation. | Drug: Early-Corticosteroids<br>* early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers<br>* Other names: Methylprednisolone;|
| No Intervention: Late CS<br>Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92% | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, dexamethazone, methylpredisolone, early recovery