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Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage

16. juli 2021 opdateret af: Alexandre Prehn Zavascki, Hospital de Clinicas de Porto Alegre

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

86

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • RS
      • Porto Alegre, RS, Brasilien, 90035-903
        • Hospital de Clínicas de Porto Alegre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients aged 18 to 65 years, seeking medical care in Hospital de Clínicas de Porto Alegre due to symptomatic COVID-19, admitted from June to November 2020 or from February to May 2021.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
P.1
Patients infected with the P.1 SARS-CoV-2 variant
Collection of clinical and laboratory data
Other variants
Patients infected with SARS-CoV-2 variants other than P.1
Collection of clinical and laboratory data

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Advanced Respiratory Support
Tidsramme: 28 days from onset of symptoms
Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.
28 days from onset of symptoms

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients in each category in the ordinal scale during hospitalization
Tidsramme: 28 days from hospital admission
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.
28 days from hospital admission
Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
Tidsramme: 28 day from hospital admission
Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.
28 day from hospital admission
28-day Mortality from onset of symptoms
Tidsramme: 28 days from onset of symptoms
Death for any cause from onset of symptoms
28 days from onset of symptoms
Time to death from onset of symptoms
Tidsramme: 28 days from onset of symptoms
Number of days from the onset of symptoms to death
28 days from onset of symptoms
28-day Mortality from hospital admission
Tidsramme: 28 days from hospital admission
Death for any cause from hospital admission
28 days from hospital admission
Time to death from hospital admission
Tidsramme: 28 days from hospital admission
Number of days from the hospital admission to death
28 days from hospital admission
Days alive and free of supplemental oxygen support.
Tidsramme: 28 day from hospital admission
Number of days alive and free of supplemental oxygen support
28 day from hospital admission
Time to invasive ventilatory support
Tidsramme: 28 days from onset of symptoms
Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
28 days from onset of symptoms
Need of critical care
Tidsramme: 28 days from hospital admission
Proportion of patients admitted to Intensive Care Unit
28 days from hospital admission
In-hospital mortality
Tidsramme: 90 days from hospital admission
Death for any cause during hospitalization
90 days from hospital admission
Number of thromboembolic event
Tidsramme: 28 day from hospital admission
Number of patients with documented deep venous thrombosis or pulmonary embolism
28 day from hospital admission
Number of patients requiring renal replacement therapy (RRT)
Tidsramme: 28 day from hospital admission
Number of patients requiring any form of RRT during hospitalization
28 day from hospital admission
Number of patients requiring prone positioning
Tidsramme: 28 day from hospital admission
Number of patients requiring prone positioning during hospitalization
28 day from hospital admission

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

15. juni 2021

Primær færdiggørelse (Faktiske)

16. juli 2021

Studieafslutning (Faktiske)

16. juli 2021

Datoer for studieregistrering

Først indsendt

13. juni 2021

Først indsendt, der opfyldte QC-kriterier

14. juni 2021

Først opslået (Faktiske)

16. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

Studiedata/dokumenter

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Covid19

Kliniske forsøg med No intervention performed

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