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

NCT04441502 | Unknown

• 1 other identifier: COVID19_OMICS
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Interstitial Pneumonia

Keywords

inflammation; thrombin generation; fibrinogenesis; fibrinolysis

Outcome Measures

Primary Outcomes (1)

• Circulating markers for COVID-19 signature

  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

  From ICU/ward admission for 8 weeks follow/up

Secondary Outcomes (2)

• COVID-19 signature and adverse cardiovascular events

  From ICU/ward admission for 8 weeks follow/up

• COVID-19 related coagulation pattern

  From ICU/ward admission for 8 weeks follow/up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 years or older
• Positivity to the test for SARS-Cov-2
• Informed consent to enrollment in the study.
• For Intensive Care patients: entry into the intensive unit and / or endotracheal intubation for no more than 4 days.
• For patients in the COVID19 wards: home hospitalization or emergency room for no more than 4 days.

You may not qualify if:

• Age less than 18 years
• Pregnant women
• Patients with malignant neoplasm, autoimmune diseases.
• Hospitalization as transfer from another hospital or other similar facility.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

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Related Links

• World Health Organization. Novel coronavirus (2019-nCoV) SITUATION REPORT - 1 21 JANUARY 2020

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, whole blood, PBMC samples

MeSH Terms

Conditions

COVID-19; Lung Diseases, Interstitial; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Ranucci, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiothoracic and Vascular Anesthesia and Intensive Care

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: March 30, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)