- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787510
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
September 27, 2021 updated by: Liontos Angelos, University Hospital, Ioannina
Effect of Covid-19 disease in clotting factors levels in hospitalized patients
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection.
Association between clotting factors levels and disease severity,morbidity and mortality in these patients.
Effect of anticoagulant therapy in the clotting factors' levels in these patients
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Epirus
-
Ioánnina, Epirus, Greece, 45500
- University General Hospital of Ioannina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA
Description
Inclusion Criteria:
- AGE> 18
- SINGED INFORMED CONSENT FORM
- POSITIVE PCR TEST FOR SARS-COV2 INFECTION
- FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT
Exclusion Criteria:
- AGE<18
- DENIAL TO PROVIDE INFORMED CONSENT FORM
- HISTORY OF MALIGNANCY
- PRIOR USE OF ANTICOAGULANT THERAPY
- PRIOR USE OF STEROIDS LONGER THAN 14 DAYS
- LACTATION-PREGNANCY
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS
Time Frame: 6 MONTHS
|
leves of cloting factors before and after treatment with LMWH
|
6 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: HARALAMPOS MILIONIS, PROFESSOR, University General Hospital of Ioannina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 23, 2020
Primary Completion (Actual)
May 23, 2021
Study Completion (Actual)
June 23, 2021
Study Registration Dates
First Submitted
March 4, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Infections
- Communicable Diseases
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- 895/23-12-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.