Identification of Predictors for the Evolution of COVID-19 Related Pneumonia by Transcriptomic and Seroproteomic (COVID_OMICS)
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|ClinicalTrials.gov Identifier: NCT04441502|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
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.
|Condition or disease|
|Covid19 Interstitial Pneumonia|
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
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Identification of Predictors for the Evolution of COVID-19 Related Interstitial Pneumonia by Transcriptomic and Seroproteomic Techniques|
|Actual Study Start Date :||March 30, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- Circulating markers for COVID-19 signature [ Time Frame: 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
- COVID-19 signature and adverse cardiovascular events [ Time Frame: From ICU/ward admission for 8 weeks follow/up ]Evaluate the association of COVID19_signature with adverse cardiovascular events. Adverse cardiovascular events are defined: death from cardiovascular causes, acute coronary syndrome, troponin T levels greater than the ninety-ninth percentile of the upper reference limit, stroke, cardiac arrhythmias, development of heart failure, venous thromboembolism
- COVID-19 related coagulation pattern [ Time Frame: From ICU/ward admission for 8 weeks follow/up ]Evaluate, in a subset of 20 patients, the characteristics of the coagulation pattern with specific tests for thrombin generation and fibrinolysis.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441502
|Contact: Ekaterina Baryshnikova, PhDfirstname.lastname@example.org|
|Contact: Rosanna Cardani, PhDemail@example.com|
|IRCCS Policlinico San Donato||Recruiting|
|San Donato Milanese, MI, Italy, 20097|
|Contact: Ekaterina Baryshnikova, PhD +390252774754 firstname.lastname@example.org|
|Contact: Rosanna Cardani, PhD +390252774644 email@example.com|
|Principal Investigator: Marco Ranucci, MD FESC|
|Sub-Investigator: Fabio Martelli, PhD|
|Sub-Investigator: Massimiliano M Corsi Romanelli, MD PhD|
|Sub-Investigator: Ekaterina Baryshnikova, PhD|
|Sub-Investigator: Rosanna Cardani, PhD|
|Principal Investigator:||Marco Ranucci, MD||IRCCS Policlinico San Donato|