COVID-19 Associated Coagulopathy in Egypt
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| ClinicalTrials.gov Identifier: NCT04507230 |
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Recruitment Status :
Recruiting
First Posted : August 11, 2020
Last Update Posted : October 27, 2020
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Sponsor:
Assiut University
Information provided by (Responsible Party):
Azza Abdelaal, Assiut University
| Tracking Information | |||||||||
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| 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 |
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| 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 |
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| 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 |
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| Condition | Coagulopathy | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
150 | ||||||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| 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 | ||||||||