COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection

• Sponsor: University Hospital, Ioannina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04787510
• Collaborator: INTERNAL MEDICINE DEPARTMENT, 1ST WARD (Other)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

Effect of Covid-19 disease in clotting factors levels in hospitalized patients

Condition or Disease	Intervention/Treatment	Phase
SARS-COV2 Infection; COVID-19 Disease; Hospitalized Patients	Drug: low molecular weight Heparin as standard of care 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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
• Actual Study Start Date: Dec 23, 2020
• Actual Primary Completion Date: May 23, 2021
• Actual Study Completion Date: Jun 23, 2021

Outcome Measures

Primary Outcome Measures

1. EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS [6 MONTHS]

   leves of cloting factors before and after treatment with LMWH

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital of Ioannina	Ioánnina	Epirus	Greece	45500

Sponsors and Collaborators

• University Hospital, Ioannina
• INTERNAL MEDICINE DEPARTMENT, 1ST WARD

Investigators

• Principal Investigator: HARALAMPOS MILIONIS, PROFESSOR, University General Hospital of Ioannina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liontos Angelos, CONSULTANT OF INTERNAL MEDICINE, University Hospital, Ioannina
• ClinicalTrials.gov Identifier: NCT04787510
• Other Study ID Numbers: 895/23-12-2020
• First Posted: Mar 8, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin

Study Results

No Results Posted as of Sep 28, 2021