Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients (ROCCO)

ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile in COVID-19 Patients

COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation.

Glycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection.

Glycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance.

Long-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.

Study Overview

• Status: Completed
• Conditions: Covid19; Chronic Pain; Morbidity, Multiple
• Intervention / Treatment: Diagnostic test: glycomic analysis; Other: Phone interview

• Study Type: Observational
• Enrollment (Actual): 374

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Aast Papa Giovanni Xxiii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.

Description

Inclusion Criteria:

• Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
• Age >18 years
• Able to express informed consent to participate in the study

Exclusion Criteria:

• patients unable to express consent,
• patients aged <18 yr,
• with signs and symptoms compatible with Covid-19 but without certified diagnosis by swab/BAL or serological examination of presence of COVID IgG antibodies

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ROCCO-A (A-symptomatic); Patients with documented COVID-19 infection and NO symptoms	Diagnostic test: glycomic analysis; Analysis of glycans on plasma samples; Other: Phone interview; patients are followed up by phone up to 1 year
ROCCO-P (Pauci-symptomatic); Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)	Diagnostic test: glycomic analysis; Analysis of glycans on plasma samples; Other: Phone interview; patients are followed up by phone up to 1 year
ROCCO-L (mild); Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT	Diagnostic test: glycomic analysis; Analysis of glycans on plasma samples; Other: Phone interview; patients are followed up by phone up to 1 year
ROCCO-M (moderate); Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities	Diagnostic test: glycomic analysis; Analysis of glycans on plasma samples; Other: Phone interview; patients are followed up by phone up to 1 year
ROCCO-S(severe); Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION	Diagnostic test: glycomic analysis; Analysis of glycans on plasma samples; Other: Phone interview; patients are followed up by phone up to 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycomic profile as predictor of long-term morbidity	Analysis of total plasmatic and IgG glycans composition; analysis of IgG glycopeptides. Correlation with pain, severity of the disease and long-term functional rehabilitation	1 year

Collaborators and Investigators

• Sponsor: Papa Giovanni XXIII Hospital
• Collaborators: GENOS

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2022

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 7, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; COVID-19; Coronavirus Infections; Chronic Pain
• Other Study ID Numbers: ROCCO-197/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No