Timing of Corticosteroids in COVID-19
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|ClinicalTrials.gov Identifier: NCT04530409|
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : January 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Corticosteroids||Drug: Early-Corticosteroids||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||752 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Timing of Corticosteroids in COVID-19|
|Actual Study Start Date :||March 20, 2021|
|Actual Primary Completion Date :||November 1, 2021|
|Actual Study Completion Date :||December 15, 2021|
Experimental: Early CS
early use of dexamethasone as early as the laboratory confirmation of inflammation.
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
No Intervention: Late CS
Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92%
- Percentage of cases that will need hospitalization [ Time Frame: 10 days ]Deterioration in the clinical picture of cases that necessitate hospitalization
- 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%
- 28-days mortality [ Time Frame: 28 days ]Percentage of cases who died within 28 days of presentation
- Severity change [ Time Frame: 10 days ]Percentages of severity
- Time to return to daily activity [ Time Frame: 60 days ]Time to return to daily activity level
- Percentage of cases with increased d-dimer [ Time Frame: 10 days ]Percentage of cases with increased d-dimer from baseline
- Percentage reduction in CRP [ Time Frame: 10 days ]Percentage reduction in CRP from baseline
- Percentage reduction in LDH [ Time Frame: 10 days ]Percentage reduction in LDH from baseline
- Percentage reduction in Ferritin [ Time Frame: 10 days ]Percentage reduction in Ferritin from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530409
|Maadi, Cairo, Egypt, 11433|
|Principal Investigator:||Emad R Issak||Assalam Clinics|