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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530409
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Emad R Issak, 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-Corticosteroids 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)
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, II. Post COVID-19 Follow-up
Actual Study Start Date : March 20, 2021
Actual Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


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%



Primary Outcome Measures :
  1. Percentage of cases that will need hospitalization [ Time Frame: 10 days ]
    Deterioration in the clinical picture of cases that necessitate hospitalization

  2. 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%

  3. 28-days mortality [ Time Frame: 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 [ Time Frame: 10 days ]
    Percentages of COVID-19 severity according to CDC 2020

  2. Time to return to daily activity [ Time Frame: 60 days ]
    Time to return to daily activity level

  3. Percentage of cases with increased d-dimer [ Time Frame: 10 days ]
    Percentage of cases with increased d-dimer from baseline

  4. Percentage reduction in CRP [ Time Frame: 10 days ]
    Percentage reduction in CRP from baseline

  5. Percentage reduction in LDH [ Time Frame: 10 days ]
    Percentage reduction in LDH from baseline

  6. Percentage reduction in Ferritin [ Time Frame: 10 days ]
    Percentage reduction in Ferritin from baseline



Information from the National Library of Medicine

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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:

  • Severe to critical COVID-19
  • 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


Locations
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Egypt
Asalam
Maadi, Cairo, Egypt, 11433
Sponsors and Collaborators
ClinAmygate
Investigators
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Principal Investigator: Emad R Issak Assalam Clinics
Publications:
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Responsible Party: Emad R Issak, Dr, ClinAmygate
ClinicalTrials.gov Identifier: NCT04530409    
Other Study ID Numbers: PR0012
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
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 R Issak, 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
Methylprednisolone
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
Neuroprotective Agents
Protective Agents