PROVID-PROGRESS - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 5
- 主要终点
- Severity of disease (number and rate of patients treated on intensive care unit or dead)
研究概览
简要总结
The aim of the joint project PROVID is to contribute to better outcome prediction for COVID-19 patients, to better clinical management, and to the development of new therapies. To this end, the investigators will collect detailed data on the course of COVID-19 patients and deeply characterize them at the molecular level. The investigators also aim to identify compounds with the potential to improve outcome.
The PROVID-PROGRESS study is being carried out as a prospective, longitudinal, multicenter observational study (case cohort study) with material asservation for genomic, transcriptomic and proteomic analyzes on adult patients with COVID-19.
详细描述
With COVID-19, severe lung damage can be associated with relative well-being. In the course of disease (several days), sudden lung failure may occur. While the lung initially shows a relatively high compliance after intubation, lung function deteriorates rapidly to severe ARDS in most patients. After intubation, patients require mechanical ventilation over a relatively long period of time (17 days on average).
To improve the clinical management of COVID-19 and its complications, there is an urgent need for clinical (e.g., scores) and molecular (e.g., biomarkers) predictors of COVID-19 progression and for new therapeutic targets. Advanced age and comorbidities have been identified as risk factors for fatal disease progression.
After study inclusion, comprehensive baseline documentation of anamnestic, clinical and laboratory data is collected on the same day if possible. In addition, all parameters are collected that may be necessary to assess the severity of a COVID-19 disease (e.g. SOFA, PSI, C (U) RB-65, ATS minor criteria). Furthermore, data is collected which, according to the current state of knowledge, may be suitable for an assessment of the prognosis of the COVID-19 disease. In particular, questions are asked about known infection risks (living environment of the patient, lifestyle, previous illnesses, immune competence), the history of symptoms and tests relating to COVID-19, preexisting medication, the familial risk of infection as well as ethnicity.
On the day of inclusion (day 0) and on study visit days 1-6 and 13 - or for discharge if this occurs before day 6 or day 13 after inclusion - routine laboratory values, score-relevant data, concomitant medication and microbiological findings are documented.
On discharge of the patient, additional information about his whereabouts is collected. If the patient dies, the date and cause of death are documented.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive detection of SARS-CoV-2-virus
- •Informed consent signed
排除标准
- •Patient participation in PROVID-CAPNETZ, PROVID-PROGRESS or PROVID- CAPSyS at an earlier time
- •simultaneous participation in PROVID-CAPNETZ
- •pregnancy
- •breast feeding period
- •active tuberculosis
结局指标
主要结局
Severity of disease (number and rate of patients treated on intensive care unit or dead)
时间窗: Between enrollment and day thirteen
次要结局
- Number and rate of patients with organ involvement (complications)(From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days)
- length of mechanical ventilation(From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days)
- Number and rate of patients with changes in quality of life, assessed by EQ-5D-3L questionnaire(From date one month before study enrolement in hospital until day 365 after recruitment)
- Number and rate of patients with COVID-19-related long-term effects assessed by EQ-5D-3L questionnaire(From date of hospitalization until day 365 after recruitment)
- Length of hospitalization(From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days)
- length of ICU treatment(From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days)
研究者
Prof. Dr. med. Martin Witzenrath
Prof. Dr. med.
Charite University, Berlin, Germany