Clinical Characterization of CoVid19 Infection: Prognostic Stratification and Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 380,000
- Locations
- 1
- Primary Endpoint
- Clinical deterioration
Study Overview
Brief Summary
- 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.
Detailed Description
Background: One of the fundamental problems of this epidemic is determined by the high percentage of SARS-CoV-2 infected patients who present rapid clinical deterioration that makes them need care in critical units. Identifying which factors are related to these more severe conditions would allow us to assess whether preventive or therapeutic measures can be put in place in advance or to better plan the services to be provided to these patients, either in this wave of the pandemic or in those that may occur in the future.
Objectives: This project aims to create stratification scales of the risk of poor evolution in patients infected by SARS-CoV-2, defined as the appearance of clinical deterioration, ARDS, sepsis, SRIS, septic shock or death. Additional goals are: 1.-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. 2.-Evaluate the effectiveness of different therapeutic schemes that have been used in this pandemic. 3.-Evaluate the effectiveness of different diagnostic tests used to predict the poor evolution of these patients 4.- Evaluate the real costs associated with the treatment of hospitalized patients with COVID-19.
Methods: The information will be extracted from the electronic medical record mostly, but will have to be done manually for certain fundamental parameters of prediction (clinical manifestations, date of onset of symptoms and duration of symptoms, and epidemiological history). Statistical analysis: Logistic regression/survival models/artificial intelligence algorithms will be created for the prediction of poor evolution of patients with CoVid-19.
Two samples are included: 1st.-All people SARS-CoV-2 positive from the Basque Country (around 380000 people) from March 2020 to January 2022; 2nd.-Patients admitted for COVID 19 in the centers participating in the study during the first wave of the pandemic, until May 31, will be included (in the case of the Basque Country, some of these patients will come from the population sample #1 described before). If there were new waves of a certain entity (more than 100 admissions in a month per center), this information would also be collected later. With the information the investigators have so far, the investigators see that the investigators would have between 6000-7000 to select. Later, patients from the autumn wave would be collected, if it were given, until the end of May 2021, due to greater temporal similarity with the first wave.
Sampling: 1st sample. - All people SARS-CoV-2 positive from the Basque Country from March 2020 to January 2022. 2nd sample. -The information to be reviewed from the medical record will be collected from the first wave of the pandemic between March-May 2020, where a random sampling will be carried out . For the second wave of autumn-winter of 2020-2021, a random sample of patients will also be collected, enough to meet the estimated sample size for this second wave. If not, the sample size will be completed with patients from the first wave.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive COVID19 people in the Basque country
- •Patients admitted (confirmed cases) by CoVid-19
Exclusion Criteria
- •Pediatric population (for objective #1 only)
Outcomes
Primary Outcomes
Clinical deterioration
Time Frame: Admission
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)
Secondary Outcomes
- Cost(Admission)
- Relief of symptoms(Admission)
- Complications at follow up(6 months)
- Mortality(6 months)
Investigators
Susana García Gutiérrez
PhD
Hospital Galdakao-Usansolo
