SARS-CoV-2 Infection Among Healthcare Professionals: Demographic Characteristics and Serological and Immune Responses Related to Progression's Phenotype (ProHEPiC-19)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,350
- 试验地点
- 1
- 主要终点
- Creation prospective cohort of health care workers
研究概览
简要总结
Introduction: Coronavirus Disease 2019 (COVID-19) has caused a global pandemic. Epidemiological and clinical inter-individual differences, symptomatology, recovery and humoral response against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) are key factors to better understand and predict the course of the pandemic. As Health Care Workers (HCWs) are caring for infected patients they are more susceptible to infection, which not only is critical for their own health but also because it results in a shortage of HCWs that seriously affects health services. Thus, maintaining the health and welfare of HCWs and enabling their rapid return to work is vital to overcome this crisis. The ProHEpiC-19 cohort presents data on the immune response of HCWs infected with SARS-CoV-2. This dynamic cohort was started in March 2020 and still continues including participants.
详细描述
Objectives:
Primary: To consolidate a prospective cohort of Health Care Workers (HCWs) to generate epidemiological and clinical high quality data. This information will be relevant to improve health policies and clinical COVID-19 protocols. This cohort will also be used as an ongoing platform to implement SARS-CoV-2 research projects with particular emphasis on incidence rate, reinfection, vaccines, and long term immune response.
Secondary:
- To determine the kinetics of SARS-CoV-2 antibodies and cellular immune response in early, mid, and long periods of immunization.
- To assess the relation between clinical variables and initial RT-PCR results with the interindividual differences in the immune response in early, mid, and long periods of immunization.
- To analyze differentially expressed cytokines as biomarkers of disease progression in early, mid, and long periods of immunization.
Methods and analysis: Longitudinal, dynamic, prospective cohort study with a 12-month follow-up, which is being conducted in 4 primary-care centres and one hospital of Northern Metropolitana Nord of Barcelona (Spain). For now, the study consists of 1350 participants divided into 2 cohorts: 1) Healthy-Exposed HCWs: 675 not infected by SARS-CoV-2 (RT-PCR with a negative result and negative SARS-CoV-2 antibodies at baseline) and 2) Infected HCWs: 675 symptomatic participants (those with new persistent cough, temperature ≥37.5°C, anosmia, or ageusia or other compatible symptoms with COVID-19) or asymptomatic participants diagnosed by positive RT-PCR test and/or SARS-CoV-2 antibodies (IgM, IgG at baseline). Primary outcomes include: humoral and cellular immune response, quantitative antibodies to SARS-Cov-2, SARS-CoV-2 antibody levels related to progression phenotype, clinical spectrum of SARS-Cov-2, symptomatology, demographics and other variables that may be predictive of immune response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.
- •To be a health care professional worker infected or exposed to SARS-CoV-2.
排除标准
- •< 18 years old
- •Not to accept to take part in the study and/or not to sign the informed consent according to the Declaration of Helsinki.
- •Not to be a health care professional worker exposed to SARS-CoV-2
结局指标
主要结局
Creation prospective cohort of health care workers
时间窗: Baseline, to 12 months after the beginning of the study
Include 675 exposed HCW participants and 675 infected HCW participants againts SARS-CoV-2, cohorts will be compared at each time point in terms of sociodemographic, epidemiological, clinical, and immunological information available. an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.
Cohort description demografics ( age, sex, academic level, housing characteristics, work variables )
时间窗: Baseline, to 12 months after the beginning of the study
Descriptive analysis of the participants will be performed using the number and percentage for categorical variables, and mean and standard deviation or median and quartiles 1 and 3 for quantitative variables, an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.
Cohort description clinical spectrum (asymptomatic, mild-moderate Illness, severe-critical)
时间窗: Baseline, to 12 months after the beginning of the study
Cohort comparison , an exploratory bivariate analysis will be performed using the tests of Chi Square, ANOVA, Kruskall-Walis, depending on the application conditions assumptions.
次要结局
- Cytokines as biomarkers of disease progression in early, mid, and long periods of immunization.(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
- Kinetics of SARS-CoV-2. IgM Nucleocapside(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
- Kinetics of SARS-CoV-2. IgG Spike(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
- Kinetics of SARS-CoV-2. T-Cell(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
- To assess the relation between clinical variables and initial RT-PCR results in the whole sample and by sex.(Baseline, to 12 months after the beginning of the study)
- To analyse the relation between clinical variables and the interindividual differences in the immune response in early, mid, and long periods of immunization in the whole sample and by sex(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
- Kinetics of SARS-CoV-2. IgG Nucleocapside(Baseline, 7 days, 15 days, 3, 6, 9 and 12 months after the beginning of the study)
研究者
Pere Toran, MN
Family Physician
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina