Identification of Predictors for the Evolution of COVID-19 Related Interstitial Pneumonia by Transcriptomic and Seroproteomic Techniques
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Circulating markers for COVID-19 signature
研究概览
简要总结
The investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from COVID-19 disease.
In particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with COVID-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage.
The study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. Genome analysis will allow the genotype to be correlated to the identified gene expression profiles.
详细描述
Study design This observational, prospective, monocentric study will make use of the recruitment of consecutive patients with COVID-19. Enrollment will last 6 months or, considering the desirable drop in infections in the next few weeks, until exhaustion of enrolled patients. Enrollment will be followed by 18 months dedicated to transcriptomics and seroproteomics investigations, for a total duration of the study of 24 months.
All patients will receive optimal medical therapy, and will undergo laboratory or instrumental examinations (chest x-ray, CT, echocardiography) as needed.
Blood samples will be taken at the entrance and then twice a week for the duration of the hospitalization (generally 2-3 weeks).
Anamnesis will be noted for all patients. In addition, at all times, patients will undergo clinical evaluation and the following laboratory tests, which include:
- blood count
- biochemistry
- standard coagulation and thrombin generation, fibrin generation and fibrinolysis (INR, PTT, D-dimer, Tissue Plasminogen Activator TPA, Plasminogen Activator Inhibitor PAI-2, Plasmin-AntiPlasmin complex PAP, Thrombin activated Fibrinolysis Inhibitor TAFI, Thrombin-AntiThrombin complex TAT, Prothrombin Fragment PF 1+2, Fibrinopeptide A)
- inflammation/infection (IL-6, procalcitonin, ferritin, PCR, sCD14, TLR3 and 4, RANTES, CCR3 and 4
- other (troponin I, NT-pro-BNP, Hb1Ac). A subgroup of patients will undergo a microcirculation analysis with SDF (Sidestream Dark Field imaging).
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
- 是
入选标准
- •Age 18 years or older
- •Positivity to the test for SARS-Cov-2
- •Informed consent to enrollment in the study.
- •For Intensive Care patients: entry into the intensive unit and / or endotracheal intubation for no more than 4 days.
- •For patients in the COVID19 wards: home hospitalization or emergency room for no more than 4 days.
排除标准
- •Age less than 18 years
- •Pregnant women
- •Patients with malignant neoplasm, autoimmune diseases.
- •Hospitalization as transfer from another hospital or other similar facility.
结局指标
主要结局
Circulating markers for COVID-19 signature
时间窗: From ICU/ward admission for 8 weeks follow/up
Identify circulating transcripts (coding and non-coding for proteins) or cytokines and chemokines which, alone or in combination (COVID19_signature), are predictive of adverse events (death, endotracheal intubation) and the prognostic capacity of COVID19_signature in the prediction of adverse events in additional to the use of standard clinical parameters
次要结局
- COVID-19 signature and adverse cardiovascular events(From ICU/ward admission for 8 weeks follow/up)
- COVID-19 related coagulation pattern(From ICU/ward admission for 8 weeks follow/up)
研究者
Marco Ranucci
Head of Cardiothoracic and Vascular Anesthesia and Intensive Care
IRCCS Policlinico S. Donato