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.
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).
Inclusion Criteria:
1. Age 18 years or older
2. Positivity to the test for SARS-Cov-2
3. Informed consent to enrollment in the study.
4. For Intensive Care patients: entry into the intensive unit and / or endotracheal
intubation for no more than 4 days.
5. For patients in the COVID19 wards: home hospitalization or emergency room for no more
than 4 days.
Exclusion Criteria:
1. Age less than 18 years
2. Pregnant women
3. Patients with malignant neoplasm, autoimmune diseases.
4. Hospitalization as transfer from another hospital or other similar facility.
IRCCS Policlinico San Donato
San Donato Milanese, MI, Italy
Investigator: Ekaterina Baryshnikova, PhD
Contact: +390252774754
ekaterina.baryshnikova@grupposandonato.it
Investigator:
Ekaterina Baryshnikova, PhD
+390252774754
ekaterina.baryshnikova@grupposandonato.it
Rosanna Cardani, PhD
+390252774644
rosanna.cardani@grupposandonato.it
Marco Ranucci, MD, Principal Investigator
IRCCS Policlinico S. Donato