One Year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19

NCT04457505 | Completed

• 1 other identifier: CIBERESUCICOVID
• Study Type: observational
• Target: 8,500
• Locations: 1 country
• Sites: 31

Brief Summary

The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome (SARS) that requires protective mechanical ventilation. Five percent of patients with SARS require extracorporeal circulation (ECMO) techniques. Global mortality data has been thus far reported in different individual publications from China. Without accounting for those patients still admitted to hospital, bona fide information (from a hospital in Wuhan) received by the PI of this project estimates that mortality of hospitalized patients is more than 10%. Evidently, mortality is concentrated in patients admitted to the ICU and those patients who require mechanical ventilation and present with SARS. As data in China was globally reported, risk factors and prognosis of patients with and without SARS who require mechanical ventilation are not definitively known. The efficacy of different treatments administered empirically or based on small, observation studies is also not known. With many still admitted at the time of publication, a recent study in JAMA about 1500 patients admitted to the ICU in the region of Lombardy (Italy) reported a crude mortality rate of 25%. The data published until the current date is merely observational, prospective or retrospective. Data has not been recorded by analysis performed with artificial intelligence (machine learning) in order to report much more personalized results. Furthermore, as it concerns patients admitted to the ICU who survive, respiratory and cardiovascular consequences, as well as quality of living are completely unknown. The study further aims to investigate quality of life and different respiratory and cardiovascular outcomes at 6 months, as well as crude mortality within 1 year after discharge of patients with COVID-19 who survive following ICU admission. Lastly, with the objective to help personalize treatment in accordance with altered biological pathways in each patient, two types of studies will be performed: 1) epigenetics and 2) predictive enrichment of biomarkers in plasma. Hypothesis

• A significant percentage of patients (20%) admitted to the hospital with COVID-19 infection is expected to require ICU admission, and need mechanical ventilation (80%) and, in a minor percentage (5%), ECMO.
• Patients who survive an acute episode during ICU hospitalization will have a yearly accumulated mortality of 40%. Those who then survive will have respiratory consequences, cardiovascular complications and poor quality of life (6 months).

Conditions

Acute Respiratory Distress Syndrome; Severe Pneumonia; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• One year mortality

  People who died after one year of follow up

  At 12 months of ICU admission

• Six month mortality

  People who died after one year of follow up

  At 6 month of ICU admission

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to Spanish ICUs.

You may qualify if:

• \. Laboratory-confirmed COVID-19 infection with either real-time PCR or Next Generation Sequencing (NGS)
• \. Admission to intensive care unit

You may not qualify if:

• \. Patients admitted to COVID-19-negative ICU

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Barcelona Supercomputing Center: collaborator
• Carlos III Health Institute: collaborator

Study Sites (31)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital General de Cataluña

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Infanta Margarita de Cabra

Cabra, Córdoba, 14940, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 30011, Spain

Location

Hospital Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

Location

Hospital Universitario Sant Joan d'Alacant

Alicante, 03550, Spain

Location

Clínica Sagrada Família

Barcelona, 08022, Spain

Location

Hospital Sagrat Cor

Barcelona, 08029, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Vall d'Hebron University Hospital, Barcelona

Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Burgos

Burgos, 09006, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital de León

León, 24008, Spain

Location

Hospital Arnau de Vilanova Lleida

Lleida, 25198, Spain

Location

Hospital Infanta Leonor de Madrid

Madrid, 28031, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

Complejo Asistencial Universitario de Palencia

Palencia, 34005, Spain

Location

Hospital Montecelo

Pontevedra, 36071, Spain

Location

Hospital Universitario Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitari Virgen de Valme

Seville, 41014, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

Hospital Clínic Universitari de València

Valencia, 46010, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Valladolid

Valladolid, 47003, Spain

Location

Hospital Nuestra Señora de Gracia

Zaragoza, 50004, Spain

Location

Related Publications (2)

• Wendel-Garcia PD, Ceccato A, Motos A, Franch-Llasat D, Perez-Moreno MO, Domenech-Spanedda MF, Chamarro-Marti E, Ferrer R, Fernandez-Barat L, Riera J, Alvarez-Napagao S, Penuelas O, Lorente JA, Almansa R, Gabarrus A, de Gonzalo-Calvo D, Gonzalez J, Anon JM, Barbera C, Barberan J, Blandino-Ortiz A, Bustamante-Munguira E, Caballero J, Carbajales-Perez C, Carbonell N, Catalan-Gonzalez M, Barral-Segade P, Manez R, de la Torre MC, Diaz E, Estella A, Gallego E, Garcia-Garmendia JL, Garnacho-Montero J, Amaya-Villar R, Gomez JM, Huerta A, Jorge-Garcia RN, Loza-Vazquez A, Marin-Corral J, Martin-Delgado MC, de la Gandara AM, Martinez-Varela IY, Lopez-Messa J, Muniz-Albaiceta G, Novo MA, Penasco Y, Pozo-Laderas JC, Ricart P, Sanchez-Miralles A, Sancho S, Socias L, Sole-Violan J, Suarez-Sipmann F, Tamayo L, Trenado J, Barbe F, Torres A, Roche-Campo F; CIBERESUCICOVID Investigators. Empirical antibiotic therapy improves outcomes in mechanically ventilated patients with COVID-19: An emulated targeted trial within a prospective, multicentre cohort study. J Infect. 2025 Feb;90(2):106411. doi: 10.1016/j.jinf.2025.106411. Epub 2025 Jan 13.

  PMID: 39814268 DERIVED

• Garcia-Hidalgo MC, Gonzalez J, Benitez ID, Carmona P, Santisteve S, Perez-Pons M, Moncusi-Moix A, Gort-Paniello C, Rodriguez-Jara F, Molinero M, Belmonte T, Torres G, Labarca G, Nova-Lamperti E, Caballero J, Bermejo-Martin JF, Ceccato A, Fernandez-Barat L, Ferrer R, Garcia-Gasulla D, Menendez R, Motos A, Penuelas O, Riera J, Torres A, Barbe F, de Gonzalo-Calvo D; CIBERESUCICOVID Project (COV20/00110, ISCIII). Identification of circulating microRNA profiles associated with pulmonary function and radiologic features in survivors of SARS-CoV-2-induced ARDS. Emerg Microbes Infect. 2022 Dec;11(1):1537-1549. doi: 10.1080/22221751.2022.2081615.

  PMID: 35603455 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For the epigenetic study, blood samples will be gathered from 1000 patients within 48 hours after admission to the ICU. The collection and preparation of plasma samples will be done in accordance with Early Detection Research Network (EDRN) Standard Operating Procedures (National Cancer Institute, USA). For the study of prognostic biomarkers, concentration of biomarkers in plasma that are key to potentially useful drugs' mechanism of action in this disease will be assessed. Plasma samples will be collected from 1000 patients within 48 hours after admission to the ICU.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pneumonia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections

Study Officials

• Antoni Torres, PhD

  Spanish Research Center for Respiratory Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: May 8, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publication
• Access Criteria: Data will be available after reasoning requested.

Locations

ES (31)