Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE (ROCCO)

• ClinicalTrials.gov Identifier: NCT04788433
• Recruitment Status: Recruiting
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Sponsor: Papa Giovanni XXIII Hospital
• Collaborator: GENOS
• Information provided by (Responsible Party): Dario Bugada, Papa Giovanni XXIII Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Chronic Pain; Morbidity, Multiple; Covid19	Diagnostic Test: glycomic analysis; Other: Phone interview

Study Design

• Study Type: Observational
• Estimated Enrollment: 615 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile
• Actual Study Start Date: March 4, 2021
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention:   Samples Without DNA

plasma samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Contacts

Contact: Dario Bugada; +393405230454; dariobugada@gmail.com

Locations

Italy

Aast Papa Giovanni Xxiii; Recruiting

Bergamo, Italy, 24127

Contact: DARIO BUGADA, MD 00390352675113 dariobugada@gmail.com

Sponsors and Collaborators

Papa Giovanni XXIII Hospital

GENOS

More Information

• Responsible Party: Dario Bugada, Anesthesiologist, Papa Giovanni XXIII Hospital
• ClinicalTrials.gov Identifier: NCT04788433
• Other Study ID Numbers: ROCCO-197/2020
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronavirus Infections; Chronic Pain; Pain; Neurologic Manifestations; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections