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COVID-19 Associated Coagulopathy in Egypt

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ClinicalTrials.gov Identifier: NCT04507230
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Azza Abdelaal, Assiut University

Tracking Information
First Submitted Date August 7, 2020
First Posted Date August 11, 2020
Last Update Posted Date October 27, 2020
Actual Study Start Date August 7, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2020)
  • Coagulation screen [ Time Frame: 1 month ]
    Full coagulation screen
  • Thrombophilia screen [ Time Frame: 1 month ]
    Full thrombophilia screen
  • VWF, FVIII [ Time Frame: 1 month ]
    VWFAg, FVIII
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Associated Coagulopathy in Egypt
Official Title Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt
Brief Summary Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.
Detailed Description studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt.

Age and sex matched controls

Condition Coagulopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 24, 2020)
150
Original Estimated Enrollment
 (submitted: August 7, 2020)
100
Estimated Study Completion Date October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with COVID 19 positive by RT- PCR

Exclusion Criteria:

  • no exclusions
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Azza Abdelaal, MD, PhD +201060033313 azzaabdelaal@aun.edu.eg
Contact: Hanan Galal, MD, PhD +201062226610 hanangalal2000@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04507230
Other Study ID Numbers 17300413
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Azza Abdelaal, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2020