NCT04359212

Brief Summary

The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

September 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 21, 2020

Last Update Submit

September 15, 2020

Conditions

COVID-19 DiseaseThromboembolism, Venous

Keywords

COVID-19 pandemicThromboembolism, VenousDeep Venous ThrombosisPulmonary Thrombosis

Outcome Measures

Primary Outcomes (1)

  • the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

    the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism

    28 days

Secondary Outcomes (1)

  • the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism

    28 days

Study Arms (2)

Medical

subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease

Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intensive

subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease

Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Interventions

thromboprophylaxis with low-molecular-weight heparin or fondaparinuxDRUG

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Also known as: thromboprophylaxis
IntensiveMedical

Eligibility Criteria

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

Consecutive patients aged \> 18 years with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease (Group 1) or to the ICU for a severe to critical disease (Group 2) will be eligible for the study.

You may qualify if:

  • aged \>= 18 years
  • needing admission to a medical hospital division or to an ICU
  • with a confirmed infection for COVID-19

You may not qualify if:

  • aged \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe Camporese

Padua, 35138, Italy

Location

Related Publications (2)

  • Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

    PMID: 35244208DERIVED

  • Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.

    PMID: 33502773DERIVED

MeSH Terms

Conditions

Venous ThromboembolismCOVID-19Venous Thrombosis

Interventions

Heparin, Low-Molecular-WeightFondaparinux

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesThrombosis

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydratesOligosaccharides

Study Officials

  • Paolo Simioni, MD

    Department of Medicine, University of Padua (I)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

May 1, 2020

Primary Completion

June 30, 2020

Study Completion

July 31, 2020

Last Updated

September 17, 2020

Record last verified: 2020-04

Locations

IT(1)