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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04530409
• Other study ID #: PR0012
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Corticosteroids
• COVID-19
• Covid19

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