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Timing of Corticosteroids in COVID-19

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ClinicalTrials.gov Identifier: NCT04530409
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Emad R Issak, ClinAmygate

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date January 31, 2022
Actual Study Start Date  ICMJE March 20, 2021
Actual Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2022)
  • Percentage of cases that will need hospitalization [ Time Frame: 10 days ]
    Deterioration in the clinical picture of cases that necessitate hospitalization
  • 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%
  • 28-days mortality [ Time Frame: 28 days ]
    Percentage of cases who died within 28 days of presentation
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Percentage of cases that will need hospitalization [ Time Frame: one to two weeks ]
    Deterioration in the clinical picture of cases that necessitate hospitalization
  • Percentage of cases that deteriorate to acute respiratory distress syndrome [ Time Frame: one to two weeks ]
    Percentage of cases whose clinical status deteriorate to acute respiratory distress syndrome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2022)
  • Percentages of COVID-19 Severity according to CDC 2020 [ Time Frame: 10 days ]
    Percentages of COVID-19 severity according to CDC 2020
  • Time to return to daily activity [ Time Frame: 60 days ]
    Time to return to daily activity level
  • Percentage of cases with increased d-dimer [ Time Frame: 10 days ]
    Percentage of cases with increased d-dimer from baseline
  • Percentage reduction in CRP [ Time Frame: 10 days ]
    Percentage reduction in CRP from baseline
  • Percentage reduction in LDH [ Time Frame: 10 days ]
    Percentage reduction in LDH from baseline
  • Percentage reduction in Ferritin [ Time Frame: 10 days ]
    Percentage reduction in Ferritin from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Percentage of cases with increased d-dimer [ Time Frame: two weeks ]
    Percentage of cases with increased d-dimer from baseline level
  • Time to recovery of diarrhea [ Time Frame: one to two weeks ]
    Time to recovery of diarrhea
  • Percentage reduction in CRP [ Time Frame: one to four weeks ]
    Percentage reduction in CRP from baseline
  • Percentage reduction in LDH [ Time Frame: one to four weeks ]
    Percentage reduction in LDH from baseline
  • Percentage reduction in ALT [ Time Frame: one to four weeks ]
    Percentage reduction in ALT from baseline
  • Percentage reduction in Ferritin [ Time Frame: one to four weeks ]
    Percentage reduction in Ferritin from baseline
  • Time to recovery of lymphopenia [ Time Frame: one to two weeks ]
    Time to recovery of lymphopenia
  • Time to recovery of cough [ Time Frame: one to two weeks ]
    Time to recovery of cough
  • Time to recovery of fever [ Time Frame: one to two weeks ]
    Time to recovery of fever
  • Time to recovery of myalgia [ Time Frame: one to two weeks ]
    Time to recovery of myalgia
  • Time to recovery of anosmia [ Time Frame: one to six weeks ]
    Time to recovery of anosmia
  • Time to recovery of dyspnea [ Time Frame: one to two weeks ]
    Time to recovery of dyspnea
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Timing of Corticosteroids in COVID-19
Official Title  ICMJE Timing of Corticosteroids in COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Corticosteroids
Intervention  ICMJE Drug: Early-Corticosteroids
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
Other Names:
  • Dexamethasone
  • Methylprednisolone
Study Arms  ICMJE
  • Experimental: Early CS
    early use of dexamethasone as early as the laboratory confirmation of inflammation.
    Intervention: Drug: Early-Corticosteroids
  • No Intervention: Late CS
    Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92%
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2022)
752
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2020)
450
Actual Study Completion Date  ICMJE December 15, 2021
Actual Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04530409
Other Study ID Numbers  ICMJE PR0012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emad R Issak, ClinAmygate
Study Sponsor  ICMJE ClinAmygate
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emad R Issak Assalam Clinics
PRS Account ClinAmygate
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP