COVID-19 Disease and Coagulopathy: Assessment of Clotting... | NCT04787510

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2020Actual

Primary Completion Date

May 23, 2021Actual

Completion Date

Jun 23, 2021Actual

First Submitted Date

Mar 4, 2021

First Submission Date that Met QC Criteria

Mar 5, 2021

First Posted Date

Mar 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2021

Last Update Posted Date

Sep 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liontos Angelos, CONSULTANT OF INTERNAL MEDICINE, University Hospital, IoanninaPrincipal Investigator

Lead Sponsor

University Hospital, IoanninaOTHER

Collaborators

Name	Class
INTERNAL MEDICINE DEPARTMENT, 1ST WARD	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low molecular weight Heparin as standard of care treatment	Drug	STANDARD OF CARE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS	leves of cloting factors before and after treatment with LMWH	6 MONTHS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HARALAMPOS MILIONIS, PROFESSOR	University Hospital, Ioannina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University General Hospital of Ioannina		Ioannina	Epirus	45500	Greece

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates