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Timing of Corticosteroids in COVID-19

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ClinicalTrials.gov Identifier: NCT04530409
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Emad Roushdy, ClinAmygate

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
Covid19 Corticosteroids Drug: Early-Dexamethasone Drug: Late-Dexamethasone 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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 : February 10, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Early CS
early use of dexamethasone as early as the laboratory confirmation of inflammation.
Drug: Early-Dexamethasone
early use of dexamethasone as early as laboratory evidence of high inflammatory markers
Other Name: Dexamethasone

Active Comparator: Late CS
Dexamethasone is to be used lately upon the deterioration of cases
Drug: Late-Dexamethasone
Use of dexamethasone on deterioration of the cases with increased severity
Other Name: Dexamethasone




Primary Outcome Measures :
  1. Percentage of cases that will need hospitalization [ Time Frame: one to two weeks ]
    Deterioration in the clinical picture of cases that necessitate hospitalization

  2. 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


Secondary Outcome Measures :
  1. Percentage of cases with increased d-dimer [ Time Frame: two weeks ]
    Percentage of cases with increased d-dimer from baseline level

  2. Time to recovery of diarrhea [ Time Frame: one to two weeks ]
    Time to recovery of diarrhea

  3. Percentage reduction in CRP [ Time Frame: one to four weeks ]
    Percentage reduction in CRP from baseline

  4. Percentage reduction in LDH [ Time Frame: one to four weeks ]
    Percentage reduction in LDH from baseline

  5. Percentage reduction in ALT [ Time Frame: one to four weeks ]
    Percentage reduction in ALT from baseline

  6. Percentage reduction in Ferritin [ Time Frame: one to four weeks ]
    Percentage reduction in Ferritin from baseline

  7. Time to recovery of lymphopenia [ Time Frame: one to two weeks ]
    Time to recovery of lymphopenia

  8. Time to recovery of cough [ Time Frame: one to two weeks ]
    Time to recovery of cough

  9. Time to recovery of fever [ Time Frame: one to two weeks ]
    Time to recovery of fever

  10. Time to recovery of myalgia [ Time Frame: one to two weeks ]
    Time to recovery of myalgia

  11. Time to recovery of anosmia [ Time Frame: one to six weeks ]
    Time to recovery of anosmia

  12. Time to recovery of dyspnea [ Time Frame: one to two weeks ]
    Time to recovery of dyspnea



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any case with COVID-19 more than or equal to 18 years
  • mild and moderate severity

Exclusion Criteria:

  • Any contra-indication for the interventional drug
  • Mentally disabled cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530409


Contacts
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Contact: Emad R Issak, MD 01272228989 dr.emad.r.h.issak@gmail.com

Locations
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Egypt
Asalam Recruiting
Maadi, Cairo, Egypt, 11433
Contact: Emad R Issak, MD    01272228989    dr.emad.r.h.issak@gmail.com   
Sponsors and Collaborators
ClinAmygate
Investigators
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Principal Investigator: Emad R Issak Assalam Clinics
Publications:
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Responsible Party: Emad Roushdy, Dr, ClinAmygate
ClinicalTrials.gov Identifier: NCT04530409    
Other Study ID Numbers: PR0012
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Roushdy, ClinAmygate:
COVID19
dexamethazone
methylpredisolone
early recovery
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action