Timing of Corticosteroids in COVID-19

Sponsor
ClinAmygate (Other)
Overall Status
Completed
CT.gov ID
NCT04530409
Collaborator
(none)
752
1
2
8.9
84.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
752 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Timing of Corticosteroids in COVID-19
Actual Study Start Date :
Mar 20, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

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%

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of cases that will need hospitalization [10 days]

      Deterioration in the clinical picture of cases that necessitate hospitalization

    2. Percentage of cases that will need oxygen supplementation [10 days]

      Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%

    3. 28-days mortality [28 days]

      Percentage of cases who died within 28 days of presentation

    Secondary Outcome Measures

    1. Percentages of COVID-19 Severity according to CDC 2020 [10 days]

      Percentages of COVID-19 severity according to CDC 2020

    2. Time to return to daily activity [60 days]

      Time to return to daily activity level

    3. Percentage of cases with increased d-dimer [10 days]

      Percentage of cases with increased d-dimer from baseline

    4. Percentage reduction in CRP [10 days]

      Percentage reduction in CRP from baseline

    5. Percentage reduction in LDH [10 days]

      Percentage reduction in LDH from baseline

    6. Percentage reduction in Ferritin [10 days]

      Percentage reduction in Ferritin from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asalam Maadi Cairo Egypt 11433

    Sponsors and Collaborators

    • ClinAmygate

    Investigators

    • Principal Investigator: Emad R Issak, Assalam Clinics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Emad R Issak, Dr, ClinAmygate
    ClinicalTrials.gov Identifier:
    NCT04530409
    Other Study ID Numbers:
    • PR0012
    First Posted:
    Aug 28, 2020
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emad R Issak, Dr, ClinAmygate
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2022