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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04530409
Other study ID # PR0012
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 20, 2021
Est. completion date October 15, 2023

Study information

Verified date September 2023
Source ClinAmygate
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 752
Est. completion date October 15, 2023
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Early-Corticosteroids
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers

Locations

Country Name City State
Egypt Asalam Maadi Cairo

Sponsors (1)

Lead Sponsor Collaborator
ClinAmygate

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of cases that will need hospitalization Deterioration in the clinical picture of cases that necessitate hospitalization 10 days
Primary Percentage of cases that will need oxygen supplementation Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92% 10 days
Primary 28-days mortality Percentage of cases who died within 28 days of presentation 28 days
Secondary Percentages of COVID-19 Severity according to CDC 2020 Percentages of COVID-19 severity according to CDC 2020 10 days
Secondary Time to return to daily activity Time to return to daily activity level 60 days
Secondary Percentage of cases with increased d-dimer Percentage of cases with increased d-dimer from baseline 10 days
Secondary Percentage reduction in CRP Percentage reduction in CRP from baseline 10 days
Secondary Percentage reduction in LDH Percentage reduction in LDH from baseline 10 days
Secondary Percentage reduction in Ferritin Percentage reduction in Ferritin from baseline 10 days
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