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

16. juli 2021 oppdatert av: 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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Faktiske)

86

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • RS
      • Porto Alegre, RS, Brasil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2021

Primær fullføring (Faktiske)

16. juli 2021

Studiet fullført (Faktiske)

16. juli 2021

Datoer for studieregistrering

Først innsendt

13. juni 2021

Først innsendt som oppfylte QC-kriteriene

14. juni 2021

Først lagt ut (Faktiske)

16. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Studiedata/dokumenter

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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