Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT04441502
Brief Summary:
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.
Detailed Description:
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).
Study:
NCT04441502
Study Brief:
Protocol Section:
NCT04441502