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.
Study Type
OBSERVATIONAL
Enrollment
86
Collection of clinical and laboratory data
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Time to Advanced Respiratory Support
Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.
Time frame: 28 days from onset of symptoms
Proportion of patients in each category in the ordinal scale during hospitalization
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.
Time frame: 28 days from hospital admission
Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, \<=100.
Time frame: 28 day from hospital admission
28-day Mortality from onset of symptoms
Death for any cause from onset of symptoms
Time frame: 28 days from onset of symptoms
Time to death from onset of symptoms
Number of days from the onset of symptoms to death
Time frame: 28 days from onset of symptoms
28-day Mortality from hospital admission
Death for any cause from hospital admission
Time frame: 28 days from hospital admission
Time to death from hospital admission
Number of days from the hospital admission to death
Time frame: 28 days from hospital admission
Days alive and free of supplemental oxygen support.
Number of days alive and free of supplemental oxygen support
Time frame: 28 day from hospital admission
Time to invasive ventilatory support
Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
Time frame: 28 days from onset of symptoms
Need of critical care
Proportion of patients admitted to Intensive Care Unit
Time frame: 28 days from hospital admission
In-hospital mortality
Death for any cause during hospitalization
Time frame: 90 days from hospital admission
Number of thromboembolic event
Number of patients with documented deep venous thrombosis or pulmonary embolism
Time frame: 28 day from hospital admission
Number of patients requiring renal replacement therapy (RRT)
Number of patients requiring any form of RRT during hospitalization
Time frame: 28 day from hospital admission
Number of patients requiring prone positioning
Number of patients requiring prone positioning during hospitalization
Time frame: 28 day from hospital admission
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