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

Primary Purpose

Covid19, Corticosteroids

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Early-Corticosteroids
Sponsored by
ClinAmygate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, dexamethazone, methylpredisolone, early recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asalam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early CS

Late CS

Arm Description

early use of dexamethasone as early as the laboratory confirmation of inflammation.

Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentages of COVID-19 Severity according to CDC 2020
Percentages of COVID-19 severity according to CDC 2020
Time to return to daily activity
Time to return to daily activity level
Percentage of cases with increased d-dimer
Percentage of cases with increased d-dimer from baseline
Percentage reduction in CRP
Percentage reduction in CRP from baseline
Percentage reduction in LDH
Percentage reduction in LDH from baseline
Percentage reduction in Ferritin
Percentage reduction in Ferritin from baseline

Full Information

First Posted
August 24, 2020
Last Updated
September 4, 2023
Sponsor
ClinAmygate
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1. Study Identification

Unique Protocol Identification Number
NCT04530409
Brief Title
Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
Official Title
Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ClinAmygate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corticosteroids
Keywords
COVID19, dexamethazone, methylpredisolone, early recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early CS
Arm Type
Experimental
Arm Description
early use of dexamethasone as early as the laboratory confirmation of inflammation.
Arm Title
Late CS
Arm Type
No Intervention
Arm Description
Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92%
Intervention Type
Drug
Intervention Name(s)
Early-Corticosteroids
Other Intervention Name(s)
Dexamethasone, Methylprednisolone
Intervention Description
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
Primary Outcome Measure Information:
Title
Percentage of cases that will need hospitalization
Description
Deterioration in the clinical picture of cases that necessitate hospitalization
Time Frame
10 days
Title
Percentage of cases that will need oxygen supplementation
Description
Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
Time Frame
10 days
Title
28-days mortality
Description
Percentage of cases who died within 28 days of presentation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Percentages of COVID-19 Severity according to CDC 2020
Description
Percentages of COVID-19 severity according to CDC 2020
Time Frame
10 days
Title
Time to return to daily activity
Description
Time to return to daily activity level
Time Frame
60 days
Title
Percentage of cases with increased d-dimer
Description
Percentage of cases with increased d-dimer from baseline
Time Frame
10 days
Title
Percentage reduction in CRP
Description
Percentage reduction in CRP from baseline
Time Frame
10 days
Title
Percentage reduction in LDH
Description
Percentage reduction in LDH from baseline
Time Frame
10 days
Title
Percentage reduction in Ferritin
Description
Percentage reduction in Ferritin from baseline
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad R Issak
Organizational Affiliation
Assalam Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asalam
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11433
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24400953
Citation
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.
Results Reference
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Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up

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