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

Covid19 Clinical Trial

— ROCCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788433
• Other study ID #: ROCCO-197/2020
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: March 2023
• Source: Papa Giovanni XXIII Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 10, 2022
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Coronavirus Infections
• COVID-19
• Covid19
• Morbidity, Multiple

Intervention

Diagnostic Test:
• glycomic analysis
Analysis of glycans on plasma samples

Other:
• Phone interview
patients are followed up by phone up to 1 year

Locations

Country	Name	City	State
Italy	Aast Papa Giovanni Xxiii	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
Papa Giovanni XXIII Hospital	GENOS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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