COVID19 Severity Prediction and Health Services Research Evaluation

NCT04463706 | Completed DMC

• 1 other identifier: COVID19_0459
• Study Type: observational
• Target: 380,000
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Objectives: 1.-To create risk stratification scales of poor evolution in patients infected by SARS-CoV-2. 2.-Evaluate the accessibility and equity that these patients have had in the different care processes, diagnostic and therapeutic procedures, with special interest in patients who came from residences, by age, gender or geographic origin.3.-Evaluate the effectiveness of different therapeutic schemes that have been used in this pandemic. 4.-Evaluate the effectiveness of different diagnostic tests used to predict the poor evolution of these patients 5.- Evaluate the real costs associated with the treatment of hospitalized patients with COVID-19 ; 2. Methods: Information will be recorded from electronic medical record: epidemiological data, onset of symptoms, comorbidities and their treatments, symptoms, analytical data, vital signs, tests performed, treatments during admission and evolution up to 3 months after discharge. Statistical analysis: The investigators will use classic survival models, logistic regression, generalized linear models and also analysis using artificial intelligence techniques . Health care costs are assessed. Applications for decision making will be derived as a product.

Conditions

Covid19

Keywords

COVID; Risk stratification; Health services research; Cost-effectiveness; Equity

Outcome Measures

Primary Outcomes (1)

• Clinical deterioration

  Clinical deterioration: Resting dyspnoea (Breathing rate \> 30 breaths/minute) or 93% oxygen saturation at rest and partial pressure of arterial oxygen ; (PaO2) /Inspired fraction of O2 \<300 mm Hg * Development of ARDS, sepsis, SIRS, shock * entry in ICU(date and days of stay) * Decease (date)

  Admission

Secondary Outcomes (4)

• Relief of symptoms

  Admission

• Mortality

  6 months

• Complications at follow up

  6 months

• Cost

  Admission

Study Arms (2)

COVID19 REDISSEC

Patients admitted (confirmed cases) by CoVid-19, excluding paediatric population. No losses are expected. A case of SARS-CoV-2 infection is defined as one that meets the laboratory criteria: PCR positive for a specific gene \[RdRp or S gene\] or PCR positive for at least 2 genes used for screening \[E or N gene\].

Other: Predictors adverse evolution

COVID19 Basque Country

All people from thw Basque Country positive to CoVid-19. A case of SARS-CoV-2 infection is defined as one that meets the laboratory criteria: PCR positive for a specific gene \[RdRp or S gene\] or PCR positive for at least 2 genes used for screening \[E or N gene\], or, as well and in the general population of the Basque Country, by detection of COVID-19 IgM or IgG antibodies.

Other: Predictors of health care provide

Interventions

Predictors adverse evolution OTHER

Predictors adverse evolution in all hospital participant admitted patients

COVID19 REDISSEC

Predictors of health care provide OTHER

Predictors of death, unequity, variability in process of care, cost in all COVID positive patients form the Basque Country

COVID19 Basque Country

Eligibility Criteria

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

Study Population

* Positive COVID19 people in the Basque Country * Patients admitted by Covid-19 to hospitals in the Basque Country, from 01/02/2020 to 01/04/2020

You may qualify if:

• Positive COVID19 people in the Basque country
• Patients admitted (confirmed cases) by CoVid-19

You may not qualify if:

• Pediatric population (for objective #1 only)

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Hospital Costa del Sol: collaborator
• Hospital del Mar: collaborator
• University Hospital of the Nuestra Señora de Candelaria: collaborator
• Instituto de Salud Carlos III: collaborator
• Hospital Universitario Araba: collaborator
• Biobizkaia Health Research Institute: collaborator
• Hospital de Basurto: collaborator
• Hospital Donostia: collaborator

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Related Publications (6)

• Quintana JM, Larrea N, Menendez L, Legarreta MJ, Gascon M, Garcia-Asensio J, Espana PP; COVID-Health Basque Country Research Group. Effectiveness of drugs employed in the treatment of COVID-19: real-world evidence. Expert Rev Respir Med. 2025 May;19(5):493-498. doi: 10.1080/17476348.2025.2488966. Epub 2025 Apr 13.

  PMID: 40186558 DERIVED

• Espana PP, Bilbao-Gonzalez A, Larrea N, Castillo-Sintes I, Garcia-Gutierrez S, Portuondo J, Villanueva A, Uranga A, Legarreta MJ, Gascon M, Quintana JM; COVID-Health Basque Country Research Group. Impact of prior SARS-COV-2 infection and vaccination on COVID-19 hospital admission and mortality amongst nursing home residents. Aging Clin Exp Res. 2023 Aug;35(8):1771-1778. doi: 10.1007/s40520-023-02446-3. Epub 2023 May 30.

  PMID: 37249860 DERIVED

• Garcia-Gutierrez S, Esteban-Aizpiri C, Lafuente I, Barrio I, Quiros R, Quintana JM, Uranga A; COVID-REDISSEC Working Group. Machine learning-based model for prediction of clinical deterioration in hospitalized patients by COVID 19. Sci Rep. 2022 May 2;12(1):7097. doi: 10.1038/s41598-022-09771-z.

  PMID: 35501359 DERIVED

• Portuondo-Jimenez J, Bilbao-Gonzalez A, Tiscar-Gonzalez V, Garitano-Gutierrez I, Garcia-Gutierrez S, Martinez-Mejuto A, Santiago-Garin J, Arribas-Garcia S, Garcia-Asensio J, Chart-Pascual J, Zorrilla-Martinez I, Quintana-Lopez JM; COVID-19-Osakidetza Working group. Modelling the risk of hospital admission of lab confirmed SARS-CoV-2-infected patients in primary care: a population-based study. Intern Emerg Med. 2022 Jun;17(4):1211-1221. doi: 10.1007/s11739-022-02931-z. Epub 2022 Feb 10.

  PMID: 35143022 DERIVED

• Esteban C, Villanueva A, Garcia-Gutierrez S, Aramburu A, Gorordo I, Quintana JM, Working Group TC. COPD in SARS-CoV-2 pandemic. baseline characteristics related to hospital admissions. Expert Rev Respir Med. 2022 Apr;16(4):477-484. doi: 10.1080/17476348.2022.2031985. Epub 2022 Apr 6.

  PMID: 35060833 DERIVED

• Espana PP, Bilbao A, Garcia-Gutierrez S, Lafuente I, Anton-Ladislao A, Villanueva A, Uranga A, Legarreta MJ, Aguirre U, Quintana JM; COVID-19-Osakidetza Working group. Predictors of mortality of COVID-19 in the general population and nursing homes. Intern Emerg Med. 2021 Sep;16(6):1487-1496. doi: 10.1007/s11739-020-02594-8. Epub 2021 Jan 5.

  PMID: 33400164 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Susana Garcia-Gutierrez, PhD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: June 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

ES (1)