Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 847
- 试验地点
- 1
- 主要终点
- Mortality at day 28
研究概览
简要总结
An observational, retrospective, classic cohort study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 by RT-PCR will be carried out. The cohort will be divided into two arms: a group of patients who received treatment with anti-SARS-CoV-2 hyperimmune serum and a group of patients not exposed to the intervention during hospitalization corresponding to the period prior to the approval of the anti-hyperimmune serum SARS-CoV-2 for use. All patients will be have structured follow-up at 14, 21 and 28 days, until discharge or death.
详细描述
A classic retrospective cohort observational study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 will be conducted. The date of admission to the cohort will be considered the date of admission. All patients will be followed with structured evaluations at 14, 21 and 28 days.
The cohort will be divided into two arms: a group of patients who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours, from the date of approval for its use; and a group of patients not exposed to said intervention during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use. CoviFab® has been authorized under special conditions by the Agency for Medicines, Food and Medical Technology (ANMAT) for the treatment of hospitalized patients with moderate to severe disease caused by the SARS-CoV-2 virus (Regulation 9175/20, 22 December 2020)
The study period that will be considered for the arm of patients exposed to anti-SARS-CoV-2 polyclonal hyperimmune serum is between January 27, 2021 and April 9, 2021. The study period to include patients not exposed to hyperimmune anti-SARS-CoV-2 serum is between September 1, 2020 to January 26, 2021. This last period was chosen because it is considered to be a time when there were no substantive differences in the diagnosis, categorization of risk, support measures or treatment of hospitalized adult patients with a confirmed diagnosis of COVID-19 pneumonia, and therefore corresponds to a valid period for comparison.
Although the "Escuela Hogar" Hospital began operating in July 2020, it was decided to exclude patients admitted for the first two months, considering that after two months of operation, the diagnostic, treatment and support systems are stable for the comparison between exposed and unexposed patients.
The study will be carried out in a collaborative manner between the Acute Campaign Hospital "Escuela Hogar" and the Hospital Italiano de Buenos Aires, which will act as the coordinating center for this study.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and younger than 80 years.
- •Hospitalized for COVID-19 at the "Escuela Hogar" Hospital in Corrientes, Argentina from September 2020 to April
- •Confirmed diagnosis of COVID-19 by SARS-CoV-2 Antigen Test or qualitative reverse transcriptase-polymerase chain reaction (qRT-PCR -GeneoDX Co, Ltd or similar) or Dosage of anti-SARS-CoV-2 IgG / IgM antibodies
- •Who received hyperimmune anti-SARS-CoV-2 serum according to the indication approved by ANMAT for use after the approval date (January 2021 to April 2021) or Patients with the same indication corresponding to the period prior to the approval date (September 2020 to January 2020)
- •With severe disease defined as individuals with tachypnea> 30 breaths per minute or oxygen saturation <94% ambient air or PaO2 / FiO2 <300, or pulmonary infiltrates> 50% on chest image.
排除标准
- •Asymptomatic disease (individuals with a positive test for SARS-CoV-2, but who do not have symptoms), mild (individuals who have compatible symptoms, but without dyspnea and with a normal chest imaging study), moderate (individuals with evidence of lower respiratory tract disease on clinical or imaging evaluation, and oxygen saturation> = 94% room air) or critical (those with respiratory failure, septic shock, and / or multi-organ dysfunction).
- •Patients who received anti-SARS-CoV-2 hyperimmune serum off-label approved by ANMAT for use according to Regulation 9175/
- •Pregnant women.
- •Lactating women.
- •Patients who are on mechanical ventilation or admitted to the ICU at hospital admission.
- •Confirmation of another concomitant microbiological cause of pneumonia other than COVID-19
结局指标
主要结局
Mortality at day 28
时间窗: 28th day since hospital admission date
Proportion of patients who die at 28th day since hospital admission date
次要结局
- Ordinal clinical scale at days 14, 21 and 28(14th, 21st and 28th days since hospital admission date)
- Days in Intensive Care Unit.(28 days follow up period since hospital admission date)
- Patients on mechanical ventilation(28 days follow up period since hospital admission date)
- Time from the date of hospitalization to the start of mechanical ventilation.(28 days follow up period since hospital admission date)
- Mortality at days 14 and 21 after hospital admission.(14th and 21st days since hospital admission date)
- Time to hospital discharge(Time to hospital discharge since hospital admission date in a 28 days follow up period)
- Time to discharge from the Intensive Care Unit(28 days follow up period since hospital admission date)
- Hospital discharge at days 14, 21 and 28.(14th, 21st and 28th days since hospital admission date)
- Patients admitted to Intensive Care Unit.(28 days follow up period since hospital admission date)
- Adverse events / serious adverse events.(28 days follow up period since hospital admission date)