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Identification of Predictors for the Evolution of COVID-19 Related Pneumonia by Transcriptomic and Seroproteomic (COVID_OMICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04441502
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : February 3, 2021
Information provided by (Responsible Party):
Marco Ranucci, IRCCS Policlinico S. Donato

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.

Condition or disease
Covid19 Interstitial Pneumonia

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).

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
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, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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
Serum, plasma, whole blood, PBMC samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
240 patients with COVID-19 will be recruited, including up to 60 patients from the intensive care and 180 from the specialized COVID19 departments of the IRCCS Policlinico San Donato. The sample size is estimated based on the average length of hospitalization of the patients and the maximum capacity of the clinical and laboratory units involved in the study.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04441502

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Contact: Ekaterina Baryshnikova, PhD +390252774754
Contact: Rosanna Cardani, PhD +390252774644

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IRCCS Policlinico San Donato Recruiting
San Donato Milanese, MI, Italy, 20097
Contact: Ekaterina Baryshnikova, PhD    +390252774754   
Contact: Rosanna Cardani, PhD    +390252774644   
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         
Sponsors and Collaborators
IRCCS Policlinico S. Donato
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Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato
Additional Information:

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Responsible Party: Marco Ranucci, Head of Cardiothoracic and Vascular Anesthesia and Intensive Care, IRCCS Policlinico S. Donato Identifier: NCT04441502    
Other Study ID Numbers: COVID19_OMICS
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Ranucci, IRCCS Policlinico S. Donato:
thrombin generation
Additional relevant MeSH terms:
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Lung Diseases, Interstitial
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases