Clinical Characteristics and In-hospital Death of a Chilean COVID-19 Prospective Cohort

NCT04758039 | Completed

• 1 other identifier: OAIC N° 1119/20
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators planned to examine a cohort of admitted patients at University of Chile Clinical Hospital with COVID-19 diagnosis. Authors report data on mortality, ICU admission, need of invasive mechanical ventilation, awake and ventilated prone positioning, use of High Flow Nasal Cannula, Thromboembolic disease, Acute Kidney Injury (AKI) and Renal Replacement Therapy. Additionally, the risk of in-hospital death according to chronic disease burden and severity of illness at admission was assessed.

Conditions

Corona Virus Infection

Keywords

Coronavirus Infection; COVID-19; SARS-CoV 2; Clinical Scenarios; Hospitalism; Hospitalist; Teaching Hospital; Awake Prone Positioning; Ventilated Prone Positioning; High Flow Nasal Cannula; HFNC; Invasive Mechanical Ventilation; Modified Charlson Comorbidity Index; Charlson Comorbidity Index; In-Hospital Mortality

Outcome Measures

Primary Outcomes (1)

• In hospital Mortality

  Death while hospitalized

  March 13th to July 10th 2020

Secondary Outcomes (5)

• Admission to an intensive care unit (ICU)

  March 13th to July 10th 2020

• Use of invasive mechanical ventilation (IMV)

  March 13th to July 10th 2020

• Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)

  March 13th to July 10th 2020

• Acute kidney injury (AKI)

  March 13th to July 10th 2020

• Renal replacement therapy (RRT).

  March 13th to July 10th 2020

Eligibility Criteria

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

Study Population

Adults with confirmed infection by SARS-CoV 2 Since the purpose of this study was to include all the patients admitted during the first 100 days of the pandemic, no sample size calculation was performed.

You may qualify if:

• Patients over 18 years
• Diagnosis of COVID-19 defined by clinical findings of acute respiratory illness (as per WHO guidelines) together with i) a positive result on reverse transcriptase chain reaction polymerase (RT-PCR) assay performed on a nasopharyngeal swab; and/or ii) chest computed tomography (CT) with typical findings of COVID-19 and absence of an alternative diagnosis

You may not qualify if:

• Length of hospital stay less than 24 hours
• Nosocomial SARS-CoV-2 infection
• Asymptomatic patients admitted for causes not related to coronavirus infection regardless their admission RT-PCR result

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clinico de la Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Francisco J Gonzalez, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 17, 2021
• Study Start: March 13, 2020
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CL (1)