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Predictors of COVID-19 Infection and Disease Progression (Portsaiduni)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484597
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Port Said University

Brief Summary:
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19

Condition or disease Intervention/treatment
Positive COVID-19 by PCR Diagnostic Test: Rt PCR

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Predictors of COVID-19 Infection and Disease Progression
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 15, 2020

Intervention Details:
  • Diagnostic Test: Rt PCR
    positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition


Primary Outcome Measures :
  1. correlation of COVID-19 antibody to PCR [ Time Frame: 1 year ]
    Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM & IgG and the severity of the clinical picture


Secondary Outcome Measures :
  1. correlation of ancillaey tests to PCR [ Time Frame: 1 year ]
    Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
Criteria

Inclusion Criteria:

  • All cases positive COVID 19 RT PCR

Exclusion Criteria:

  • cases with chronic diseases ( cancers, diabetes Liver or Kidney )

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): NCT04484597


Locations
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Egypt
Prof. Refat Sadeq Recruiting
Port Said, Egypt, 22223
Contact: Refat A. Sadeq, Ph D    01003737012    refat.sadek@med.psu.edu.eg   
Sponsors and Collaborators
Port Said University
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Responsible Party: Port Said University
ClinicalTrials.gov Identifier: NCT04484597    
Other Study ID Numbers: Prof. Refat Sadeq
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
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 Port Said University:
COVID 19
Rt PCR
CT
Rapid tests
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes