Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
- Conditions
- Covid19COVID-19 PneumoniaSARS-CoV-2 Infection
- Interventions
- Other: No intervention performed
- Registration Number
- NCT04928469
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- Patients admitted for reasons other than COVID-19
- Asymptomatic patients with positive routine screening with RT-PCR
- Patients transferred from other institutions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Other variants No intervention performed Patients infected with SARS-CoV-2 variants other than P.1 P.1 No intervention performed Patients infected with the P.1 SARS-CoV-2 variant
- Primary Outcome Measures
Name Time Method Time to Advanced Respiratory Support 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.
- Secondary Outcome Measures
Name Time Method 28-day Mortality from hospital admission 28 days from hospital admission Death for any cause from hospital admission
Time to death from hospital admission 28 days from hospital admission Number of days from the hospital admission to death
Need of critical care 28 days from hospital admission Proportion of patients admitted to Intensive Care Unit
Number of patients requiring renal replacement therapy (RRT) 28 day from hospital admission Number of patients requiring any form of RRT during hospitalization
Proportion of patients in each category in the ordinal scale during hospitalization 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.
Days alive and free of supplemental oxygen support. 28 day from hospital admission Number of days alive and free of supplemental oxygen support
Time to invasive ventilatory support 28 days from onset of symptoms Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
In-hospital mortality 90 days from hospital admission Death for any cause during hospitalization
28-day Mortality from onset of symptoms 28 days from onset of symptoms Death for any cause from onset of symptoms
Number of thromboembolic event 28 day from hospital admission Number of patients with documented deep venous thrombosis or pulmonary embolism
Number of patients requiring prone positioning 28 day from hospital admission Number of patients requiring prone positioning during hospitalization
Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization 28 day from hospital admission Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, \<=100.
Time to death from onset of symptoms 28 days from onset of symptoms Number of days from the onset of symptoms to death
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil