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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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RS
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Porto Alegre, RS, Brazilië, 90035-903
- Hospital de Clinicas de Porto Alegre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to Advanced Respiratory Support
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of patients in each category in the ordinal scale during hospitalization
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020-0163
Plan Individuele Deelnemersgegevens (IPD)
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Bestudeer gegevens/documenten
Informatie over medicijnen en apparaten, studiedocumenten
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