Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04758039 |
| Other study ID # |
OAIC N° 1119/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2020 |
| Est. completion date |
July 10, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
University of Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
