NCT04457505

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

Completed Last updated 21 July 2022

What this trial tests

trial in Acute Respiratory Distress Syndrome in 8,500 participants. Completed in 31 December 2021.

Timeline

8 May 2020

Primary endpoint
30 September 2021

31 December 2021

Quick facts

Lead sponsor	Consorcio Centro de Investigación Biomédica en Red (CIBER)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	8,500
Start date	8 May 2020
Primary completion	30 September 2021
Estimated completion	31 December 2021
Sites	31 locations across Spain

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• Severe Pneumonia — all drugs for Severe Pneumonia →
• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER) — full company profile →

Who can join

Eligibility, any sex, with Acute Respiratory Distress Syndrome or Severe Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral RNA load in plasma is associated with critical illness and a dysregulated host response in COVID-19.
   Bermejo-Martin JF, González-Rivera M, Almansa R, Micheloud D, et al · · 2020 · cited 199× · PMID 33317616 · DOI 10.1186/s13054-020-03398-0
2. Pulmonary Function and Radiologic Features in Survivors of Critical COVID-19: A 3-Month Prospective Cohort.
   González J, Benítez ID, Carmona P, Santisteve S, et al · · 2021 · cited 195× · PMID 33676998 · DOI 10.1016/j.chest.2021.02.062
3. Circulating microRNA profiles predict the severity of COVID-19 in hospitalized patients.
   de Gonzalo-Calvo D, Benítez ID, Pinilla L, Carratalá A, et al · · 2021 · cited 108× · PMID 34048985 · DOI 10.1016/j.trsl.2021.05.004
4. Impact of time to intubation on mortality and pulmonary sequelae in critically ill patients with COVID-19: a prospective cohort study.
   González J, Benítez ID, de Gonzalo-Calvo D, Torres G, et al · · 2022 · cited 45× · PMID 35012662 · DOI 10.1186/s13054-021-03882-1
5. Effects of intubation timing in patients with COVID-19 throughout the four waves of the pandemic: a matched analysis.
   Riera J, Barbeta E, Tormos A, Mellado-Artigas R, et al · · 2023 · cited 41× · PMID 36396142 · DOI 10.1183/13993003.01426-2022
6. The evolution of the ventilatory ratio is a prognostic factor in mechanically ventilated COVID-19 ARDS patients.
   Torres A, Motos A, Riera J, Fernández-Barat L, et al · · 2021 · cited 38× · PMID 34517881 · DOI 10.1186/s13054-021-03727-x
7. One Year Overview and Follow-Up in a Post-COVID Consultation of Critically Ill Patients.
   González J, Zuil M, Benítez ID, de Gonzalo-Calvo D, et al · · 2022 · cited 30× · PMID 35911414 · DOI 10.3389/fmed.2022.897990
8. Major candidate variables to guide personalised treatment with steroids in critically ill patients with COVID-19: CIBERESUCICOVID study.
   Torres A, Motos A, Cillóniz C, Ceccato A, et al · · 2022 · cited 28× · PMID 35727348 · DOI 10.1007/s00134-022-06726-w