NCT04824677

Brief Summary

Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge. Through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to COVID-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. The final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
971

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

May 18, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

March 24, 2021

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)

    Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).

    18 months

Secondary Outcomes (4)

  • Death

    18 months

  • Mechanical ventilation

    18 months

  • ICU admission

    18 months

  • Thrombotic event

    18 months

Interventions

Hospital treatment of COVID disease

Eligibility Criteria

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

Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for COVID19.

You may qualify if:

  • Laboratory confirmed COVID-19 infection.
  • Hospitalization in a center in the Lleida healthcare region.

You may not qualify if:

  • Patients admitted with repeatedly negative COVID-19 test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitari Santa Maria

Lleida, 25198, Spain

Location

Related Publications (1)

  • Belmonte T, Perez-Pons M, Benitez ID, Molinero M, Garcia-Hidalgo MC, Rodriguez-Munoz C, Gort-Paniello C, Moncusi-Moix A, Made A, Devaux Y, Martelli F, Ortega A, Gonzalez J, Torres G, Barbe F, de Gonzalo-Calvo D. Addressing the unsolved challenges in microRNA-based biomarker development: Suitable endogenous reference microRNAs for SARS-CoV-2 infection severity. Int J Biol Macromol. 2024 Jun;269(Pt 2):131926. doi: 10.1016/j.ijbiomac.2024.131926. Epub 2024 Apr 28.

Biospecimen

Retention: SAMPLES WITH DNA

1 tube EDTA

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ferran Barbé, MD

    Spanish Respiratory Society (SEPAR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Respiratory Medicine

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 1, 2021

Study Start

May 18, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations