Risk Factors, Personalized Prognoses and 1-year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
Trial ID: NCT04457505
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2020-05-08
Completion date: 2021-12-31
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborators: Barcelona Supercomputing Center; Carlos III Health Institute
Conditions: Acute Respiratory Distress Syndrome; Severe Pneumonia; Respiratory Failure
Locations: Hospital Universitario de Bellvitge; Hospital de Mataró; Hospital General de Cataluña; Hospital Infanta Margarita de Cabra; Hospital Universitario Lucus Augusti; Hospital Son Llatzer; Hospital Álvaro Cunqueiro; Hospital Universitario Central de Asturias; Hospital Verge de la Cinta; Hospital Universitario Sant Joan d'Alacant; Clínica Sagrada Família; Hospital Sagrat Cor; Hospital Universitari Vall d'Hebron; Vall d'Hebron University Hospital, Barcelona; Hospital Clinic; Hospital Burgos; Hospital San Pedro de Alcantara; Hospital de León; Hospital Arnau de Vilanova Lleida; Hospital Infanta Leonor de Madrid; Hospital Universitario La Paz; Complexo Hospitalario Universitario de Ourense; Complejo Asistencial Universitario de Palencia; Hospital Montecelo; Hospital Universitario Salamanca; Hospital Universitari Virgen de Valme; Hospital Universitari de Tarragona Joan XXIII; Hospital Clínic Universitari de València; Hospital Universitari i Politècnic La Fe; Hospital Universitario Valladolid; Hospital Nuestra Señora de Gracia
Countries: Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain
Enrollment: 8500
Age range: None - None
Sex: ALL

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).

Eligibility criteria:
Inclusion Criteria:

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

Exclusion Criteria:

* 1\. Patients admitted to COVID-19-negative ICU

Outcomes:
One year mortality; Six month mortality