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

Clinical Characteristics and In-hospital Death During the First 100 Days of the COVID-19 Pandemic in Chile: A Prospective Cohort Study From a University Hospital

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.

Study Overview

• Status: Completed
• Conditions: Corona Virus Infection

Detailed Description

This is a prospective cohort study of adult inpatients at University of Chile Clinical Hospital, located in Santiago, Chile. We enrolled all patients aged over 18 years detected with COVID-19 admitted to the emergency department between March 1-June 11, 2020 through prospective identification using daily admission records. Briefly, COVID-19 diagnosis was made when patients had clinical findings of acute respiratory illness 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. We intended to include all admitted patients during the first 100 days of the pandemic; therefore, no sample size calculation was performed. We excluded patients with length of stay less than 24 hours, nosocomial SARS-CoV-2 infection, and asymptomatic patients admitted for causes unrelated to SARS-CoV-2 infection regardless of their admission RT-PCR result.

All data were prospectively recorded for each included patient at admission and then daily until the end of the follow-up. Records were consulted by trained physicians, using a standardized data collection form, and then checked by a team of four physicians. Data discrepancy was agreed between the same clinicians.

Recorded data included demographic characteristics, comorbidities, disease onset time, associated symptoms, vital signs at the emergency department, laboratory test performed within 24 hours after admission, characteristics of the first chest CT, medication and supportive care provided, and length of stay at the hospital.

The use of antibiotics, antiviral therapy, corticosteroids, advanced oxygen delivery techniques, need for invasive mechanical ventilation (IMV), awake and ventilated prone position, use of vasopressor drugs, and need for renal replacement therapy (RRT) were explicitly recorded. Clinical management and use of these therapies were based on national recommendations from scientific societies and local protocols. Outcome collection and assignment are explained below.

Laboratory confirmation of SARS-CoV-2 infection was made using RT-PCR of nasopharyngeal swabs. All laboratory, microbiologic, and radiologic assessments were performed at the discretion of the treating physicians who were encouraged to follow local clinical guidelines. Film-array on the nasopharyngeal swab was performed for viral co-infection assessment, and urinary antigens. (pneumococcal and legionella) and blood cultures were performed for bacterial co-infection assessment. Chest radiographs and CT were also performed for all inpatients by experienced radiologists and classified as COVID-19-unrelated, typical or atypical pattern, and unspecified.

• Study Type: Observational
• Enrollment (Actual): 395

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Hospital Clínico de la Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In hospital Mortality	Death while hospitalized	March 13th to July 10th 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission to an intensive care unit (ICU)	Admission to an intensive care unit (ICU)	March 13th to July 10th 2020
Use of invasive mechanical ventilation (IMV)	Days from admission and length of IMV	March 13th to July 10th 2020
Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)	Described as a positive US exploration of the arms or legs, and a positive CT Scan	March 13th to July 10th 2020
Acute kidney injury (AKI)	AKI, as per defined by the Kidney Disease Improving Global Outcomes (KDIGO) initiative	March 13th to July 10th 2020
Renal replacement therapy (RRT).	Days from admission and length of RRT	March 13th to July 10th 2020

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Francisco J Gonzalez, MD, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; HFNC; Coronavirus Infection; SARS-CoV 2; Clinical Scenarios; Hospitalism; Hospitalist; Teaching Hospital; Awake Prone Positioning; Ventilated Prone Positioning; High Flow Nasal Cannula; Invasive Mechanical Ventilation; Modified Charlson Comorbidity Index; Charlson Comorbidity Index; In-Hospital Mortality
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: OAIC N° 1119/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Anonymized data will be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No