Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Time to Advanced Respiratory Support
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients admitted for reasons other than COVID-19
- •Asymptomatic patients with positive routine screening with RT-PCR
- •Patients transferred from other institutions
结局指标
主要结局
Time to Advanced Respiratory Support
时间窗: 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.
次要结局
- 28-day Mortality from hospital admission(28 days from hospital admission)
- Time to death from hospital admission(28 days from hospital admission)
- Need of critical care(28 days from hospital admission)
- Number of patients requiring renal replacement therapy (RRT)(28 day from hospital admission)
- Proportion of patients in each category in the ordinal scale during hospitalization(28 days from hospital admission)
- Days alive and free of supplemental oxygen support.(28 day from hospital admission)
- Time to invasive ventilatory support(28 days from onset of symptoms)
- In-hospital mortality(90 days from hospital admission)
- 28-day Mortality from onset of symptoms(28 days from onset of symptoms)
- Number of thromboembolic event(28 day from hospital admission)
- Number of patients requiring prone positioning(28 day from hospital admission)
- Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization(28 day from hospital admission)
- Time to death from onset of symptoms(28 days from onset of symptoms)
研究者
Alexandre Prehn Zavascki
Principal Investigator
Hospital de Clinicas de Porto Alegre