Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death
研究概览
简要总结
This study is a retrospective pharmacological study, of a historical cohort. Collection of Retrospective data from February 2020 to 30 September 2021 The index date is the date of COVID-19 positive PCR test. The data will be collected until last news (last clinical visit or death).
There are no defined study visits. In the course of the study, the clinical data recorded are those corresponding to the standard medical procedure.
The goal of this study is to assess the impact on continuing or stopping adalimumab treatment on the occurrence of a severe COVID-19 (Coronavirus Disease 2019) in patients with Immune-Mediated Inflammatory Disease (IMID), during the first month after the diagnosis of SARS-CoV-2 infection.
To our knowledge, no comparisons have been performed between IMID patients stopping or not their maintenance treatment. In the context of the COVID-19 epidemic, the goal is to minimize the risk of disease flare while simultaneously minimizing the risk of severe COVID-19. In this study, we hypothesized that patients treated by adalimumab for IMID might not be susceptible to severe COVID-19 disease course.
详细描述
Immune-mediated inflammatory disease (IBD or rheumatic disease) patients treated with adalimumab with positive PCR COVID-19 diagnosis will be enrolled by physicians.
There will be four predefined and balanced group:
- Adalimumab withdrawal in patients with IBD
- Adalimumab continuation in patients with IBD
- Adalimumab withdrawal in patients with RA, PsA, axSpA, and nrxSpA
- Adalimumab continuation in patients with RA, PsA, axSpA, and nrxSpA n = 312 subjects for groups 1+3 together and 312 subjects for groups 2+4 together.
All data will be described by percentages (categorical variables) and mean +/- standard deviation and quartiles (continuous variables). The median time of follow-up survival data will also be detailed for each event of interest (admission to intensive care unit, need to a mechanical ventilation during hospitalization, death). Kaplan Meier curve will describe the probability of the occurrence of a severe SARS-CoV-2 infection (see primary endpoint for definition).
Time to analysis - better define - time to severity of the event. Occurrence (yes/no)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •diagnosis of immune-mediated inflammatory disease:
- •IBD: CD, UC or undetermined colitis
- •Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
- •patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
- •COVID-19 positive PCR test
- •minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis
- •minimum follow-up of one month after SARS-CoV-2 infection diagnosis
排除标准
- •Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
- •Patients with COPD or lung co-morbidities
- •Pregnant, parturient, or breastfeeding woman
- •Minor person (non-emancipated)
- •Adult person under legal protection (any form of public guardianship)
- •Adult person incapable of giving consent and not under legal protection
- •Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1 of the Public Health Code.
结局指标
主要结局
composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death
时间窗: first month after the diagnosis of SARS-CoV-2 infection
The primary endpoint is the occurrence of a severe SARS-CoV-2 infection, which will be defined by a composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death, during the first month after the diagnosis of SARS-CoV-2 infection.
次要结局
- occurrence of IMID flare(from diagnosis of SARS-CoV-2 infection to enrollment)
研究者
Silvio Danese
Gastroenterologist
IRCCS San Raffaele