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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
Sponsor:
Information provided by (Responsible Party):
Marco Ranucci, IRCCS Policlinico S. Donato

Study Description
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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).
Study Design
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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, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Outcome Measures
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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

Eligibility Criteria
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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.
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04441502


Contacts
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Contact: Ekaterina Baryshnikova, PhD +390252774754 ekaterina.baryshnikova@grupposandonato.it
Contact: Rosanna Cardani, PhD +390252774644 rosanna.cardani@grupposandonato.it

Locations
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Italy
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, MI, Italy, 20097
Contact: Ekaterina Baryshnikova, PhD    +390252774754    ekaterina.baryshnikova@grupposandonato.it   
Contact: Rosanna Cardani, PhD    +390252774644    rosanna.cardani@grupposandonato.it   
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
Investigators
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Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato
More Information
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Additional Information:

Publications:

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Responsible Party: Marco Ranucci, Head of Cardiothoracic and Vascular Anesthesia and Intensive Care, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT04441502    
Other Study ID Numbers: COVID19_OMICS
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
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:
inflammation
thrombin generation
fibrinogenesis
fibrinolysis
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections