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

September 4, 2023 updated by: Emad R Issak, ClinAmygate
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

752

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Maadi, Cairo, Egypt, 11433
        • Asalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early CS
early use of dexamethasone as early as the laboratory confirmation of inflammation.
Drug: Early-Corticosteroids
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
Other Names:
  • Dexamethasone
  • Methylprednisolone
No Intervention: Late CS
Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of cases that will need hospitalization
Time Frame: 10 days
Deterioration in the clinical picture of cases that necessitate hospitalization
10 days
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%
10 days
28-days mortality
Time Frame: 28 days
Percentage of cases who died within 28 days of presentation
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages of COVID-19 Severity according to CDC 2020
Time Frame: 10 days
Percentages of COVID-19 severity according to CDC 2020
10 days
Time to return to daily activity
Time Frame: 60 days
Time to return to daily activity level
60 days
Percentage of cases with increased d-dimer
Time Frame: 10 days
Percentage of cases with increased d-dimer from baseline
10 days
Percentage reduction in CRP
Time Frame: 10 days
Percentage reduction in CRP from baseline
10 days
Percentage reduction in LDH
Time Frame: 10 days
Percentage reduction in LDH from baseline
10 days
Percentage reduction in Ferritin
Time Frame: 10 days
Percentage reduction in Ferritin from baseline
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinAmygate

Investigators

  • Principal Investigator: Emad R Issak, Assalam Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Estimated)

October 15, 2023

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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