NCT04787510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

March 4, 2021

Last Update Submit

September 27, 2021

Conditions

SARS-COV2 InfectionCOVID-19 DiseaseHospitalized Patients

Outcome Measures

Primary Outcomes (1)

  • EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS

    leves of cloting factors before and after treatment with LMWH

    6 MONTHS

Interventions

low molecular weight Heparin as standard of care treatmentDRUG

STANDARD OF CARE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

PLASMA AND CLOTTING FACTORS

MeSH Terms

Conditions

COVID-19

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • HARALAMPOS MILIONIS, PROFESSOR

    University Hospital, Ioannina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT OF INTERNAL MEDICINE

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 8, 2021

Study Start

December 23, 2020

Primary Completion

May 23, 2021

Study Completion

June 23, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

GR(1)