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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
RS
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Porto Alegre, RS, Brésil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Advanced Respiratory Support
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of patients in each category in the ordinal scale during hospitalization
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 28 days from hospital admission
|
Death for any cause from hospital admission
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28 days from hospital admission
|
|
Time to death from hospital admission
Délai: 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.
Délai: 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
Délai: 28 days from onset of symptoms
|
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
|
|
Need of critical care
Délai: 28 days from hospital admission
|
Proportion of patients admitted to Intensive Care Unit
|
28 days from hospital admission
|
|
In-hospital mortality
Délai: 90 days from hospital admission
|
Death for any cause during hospitalization
|
90 days from hospital admission
|
|
Number of thromboembolic event
Délai: 28 day from hospital admission
|
Number of patients with documented deep venous thrombosis or pulmonary embolism
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28 day from hospital admission
|
|
Number of patients requiring renal replacement therapy (RRT)
Délai: 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
|
|
Number of patients requiring prone positioning
Délai: 28 day from hospital admission
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Number of patients requiring prone positioning during hospitalization
|
28 day from hospital admission
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-0163
Plan pour les données individuelles des participants (IPD)
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Données/documents d'étude
Informations sur les médicaments et les dispositifs, documents d'étude
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