Corticosteroids, Covid19
Conditions
Keywords
COVID19, dexamethazone, methylpredisolone, early recovery
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.
Interventions
DRUGEarly-Corticosteroids
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
Sponsors
ClinAmygate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of cases that will need hospitalization | 10 days | Deterioration in the clinical picture of cases that necessitate hospitalization |
| Percentage of cases that will need oxygen supplementation | 10 days | Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92% |
| 28-days mortality | 28 days | Percentage of cases who died within 28 days of presentation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in CRP | 10 days | Percentage reduction in CRP from baseline |
| Percentages of COVID-19 Severity according to CDC 2020 | 10 days | Percentages of COVID-19 severity according to CDC 2020 |
| Percentage reduction in Ferritin | 10 days | Percentage reduction in Ferritin from baseline |
| Percentage reduction in LDH | 10 days | Percentage reduction in LDH from baseline |
| Time to return to daily activity | 60 days | Time to return to daily activity level |
| Percentage of cases with increased d-dimer | 10 days | Percentage of cases with increased d-dimer from baseline |
Countries
Egypt
Outcome results
None listed