Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the country has been observed. Recent studies indicate that this variant is associated with higher transmissibility; it is not known whether it is associated with clinical severity and higher mortality rates.
This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre. Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2 N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020 to November 2020 and 43 from February 2021 to May 2021) were sequenced for further evaluation. These dates were defined since the emergence of P.1 lineage in late January.
Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings and mortality were collected from each patient. This retrospective cohort aims to assess whether the number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms differs among patients infected with the P.1 SARS-CoV-2 variant and those infected with other variants.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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RS
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Porto Alegre, RS, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients aged 18 to 65 years
- Hospital admission due to symptomatic COVID-19
- RT-PCR was collected from June to November 2020 or from February to May 2021
Exclusion Criteria:
- Patients admitted for reasons other than COVID-19
- Asymptomatic patients with positive routine screening with RT-PCR
- Patients transferred from other institutions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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P.1
Patients infected with the P.1 SARS-CoV-2 variant
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Collection of clinical and laboratory data
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Other variants
Patients infected with SARS-CoV-2 variants other than P.1
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Collection of clinical and laboratory data
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Advanced Respiratory Support
Periodo de tiempo: 28 days from onset of symptoms
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Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.
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28 days from onset of symptoms
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of patients in each category in the ordinal scale during hospitalization
Periodo de tiempo: 28 days from hospital admission
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Proportion of patients in each category in the ordinal scale during hospitalization.
Ordinal scale levels: 1, patient not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation or extracorporeal membrane oxygenation; and 6, death.
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28 days from hospital admission
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Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
Periodo de tiempo: 28 day from hospital admission
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Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.
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28 day from hospital admission
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28-day Mortality from onset of symptoms
Periodo de tiempo: 28 days from onset of symptoms
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Death for any cause from onset of symptoms
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28 days from onset of symptoms
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Time to death from onset of symptoms
Periodo de tiempo: 28 days from onset of symptoms
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Number of days from the onset of symptoms to death
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28 days from onset of symptoms
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28-day Mortality from hospital admission
Periodo de tiempo: 28 days from hospital admission
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Death for any cause from hospital admission
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28 days from hospital admission
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Time to death from hospital admission
Periodo de tiempo: 28 days from hospital admission
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Number of days from the hospital admission to death
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28 days from hospital admission
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Days alive and free of supplemental oxygen support.
Periodo de tiempo: 28 day from hospital admission
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Number of days alive and free of supplemental oxygen support
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28 day from hospital admission
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Time to invasive ventilatory support
Periodo de tiempo: 28 days from onset of symptoms
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Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
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28 days from onset of symptoms
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Need of critical care
Periodo de tiempo: 28 days from hospital admission
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Proportion of patients admitted to Intensive Care Unit
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28 days from hospital admission
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In-hospital mortality
Periodo de tiempo: 90 days from hospital admission
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Death for any cause during hospitalization
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90 days from hospital admission
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Number of thromboembolic event
Periodo de tiempo: 28 day from hospital admission
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Number of patients with documented deep venous thrombosis or pulmonary embolism
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28 day from hospital admission
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Number of patients requiring renal replacement therapy (RRT)
Periodo de tiempo: 28 day from hospital admission
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Number of patients requiring any form of RRT during hospitalization
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28 day from hospital admission
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Number of patients requiring prone positioning
Periodo de tiempo: 28 day from hospital admission
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Number of patients requiring prone positioning during hospitalization
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28 day from hospital admission
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-0163
Plan de datos de participantes individuales (IPD)
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Datos del estudio/Documentos
Información sobre medicamentos y dispositivos, documentos del estudio
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