Persistent COVID-19 Registry in Navarre. (Persicov-19)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Describe the demographic, clinical and analytical characteristics of patients with persistent COVID in our setting.
研究概览
简要总结
The goal of this observational study is to deepen our understanding of long COVID by determining the prevalence of the main complications and medium- to long-term sequelae of COVID-19 in Navarre.
Sociodemographic variables such as age, sex, ethnicity, smoking history, and comorbidities will be collected, as well as clinical and disease management variables such as persistent COVID-19 symptoms at 3 months, all with the aim of characterizing patients with long COVID.
All patient data will be collected in a single visit.
详细描述
COVID-19 is the largest pandemic faced by the public health system in the last hundred years. The medium- and long-term consequences of SARS-COV-2 infection are currently unknown. Studies on coronavirus-induced lung damage in previous epidemics such as SARS-CoV and MERS-CoV have shown an increase in morbidity and mortality due to pulmonary fibrosis as a consequence of adult respiratory distress syndrome (ARDS) caused by these viruses. COVID-19 has also been shown to be a multisystemic disease with the potential to affect multiple organs or systems, damaged directly by the virus and/or indirectly by a dysfunctional immune response and/or by the supportive therapies used.
The healthcare system is currently focusing on the acute care of this disease, but continuous monitoring of these patients is necessary since many of them continue to have symptoms after the acute phase of the disease, known as persistent COVID-19 or long COVID. Long COVID or persistent COVID is the term used to describe the disease in people who have recovered from the disease but still report lasting effects from the infection or who have symptoms for longer than would be expected².
The study published by Carfi et al, conducted in a hospital in Rome, has shown that 9 out of 10 patients (87%) who had been discharged from hospital with COVID-19 60 days after discharge still reported at least one symptom of COVID-19³.
The investigators believe that once this peak phase of the epidemic has passed, it is very important to monitor the progress of patients who have suffered a moderate or severe infection in order to assess the presence of complications in the medium and short term. For this reason, it is necessary to implement a coordinated care protocol for patients diagnosed with persistent COVID-19 or with sequelae, involving both primary and hospital care, with a specific monographic consultation, as has been done in other centres⁴ and as agreed between the Spanish Society of Internal Medicine (SEMI) and the Spanish Society of Primary Care Physicians (SEMERGEN)⁵.
The establishment of a specific care pathway for persistent COVID patients, together with the creation of a registry of these patients that collects information on their demographic and clinical characteristics, will make it possible to determine the prevalence of complications in this population and will provide the infrastructure and basis necessary for carrying out future short- to medium-term clinical projects aimed at the prevention and treatment of persistent COVID disease in Navarra.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of confirmed SARS-CoV-2 infection
- •Presentation of symptoms that have persisted for more than 3 months after SARS-CoV-2 infection
- •The patient reports any of the symptoms listed in the clinical assessment questionnaire or checklist.
排除标准
- •The symptom(s) referred to already existed prior to acute SARS-CoV-2 infection.
研究组 & 干预措施
Patients diagnosed with long COVID
结局指标
主要结局
Describe the demographic, clinical and analytical characteristics of patients with persistent COVID in our setting.
时间窗: Basal visit
The following sociodemographic variables: age, gender, ethnicity, smoking history, and comorbidities, and analytical variables, will be collected.
Establish the prevalence of different symptoms, complications and/or medium- to long-term sequelae of COVID-19 in Navarre.
时间窗: Basal visit
6\) Diagnosis of: * Thromboembolic disease (deep vein thrombosis and/or pulmonary embolism at discharge and/or pulmonary thromboembolism). * Acute cerebrovascular accident (embolic and/or atherothrombotic: referred to as stroke/ACVA/TIA/cerebral infarction) during admission for COVID-19. Establish assessment criteria by Internal Medicine and/or Neurology. * Peripheral arterial ischaemic event during admission for COVID-19 * Acute complication of pre-existing coronary artery disease and/or acute coronary event (acute coronary syndrome or ACS). * suspicion and/or diagnosis of myopericarditis during admission. * criteria for acute hepatitis (GOT and/or GPT \>5 times normal range (\>200 during admission) and/or liver dysfunction (Br \>3 mg/dl).
次要结局
未报告次要终点
