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

Completed

• Conditions: Morbidity, Multiple; Chronic Pain; Covid19
• Interventions: Diagnostic Test: glycomic analysis; Other: Phone interview

• Registration Number: NCT04788433
• Lead Sponsor: Papa Giovanni XXIII Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-09
• Primary Completion: 2021-09-10
• Study Completion: 2022-09-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROCCO-A (A-symptomatic)	glycomic analysis	Patients with documented COVID-19 infection and NO symptoms
ROCCO-P (Pauci-symptomatic)	glycomic analysis	Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)
ROCCO-M (moderate)	glycomic analysis	Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities
ROCCO-L (mild)	glycomic analysis	Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT
ROCCO-M (moderate)	Phone interview	Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities
ROCCO-S(severe)	Phone interview	Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION
ROCCO-A (A-symptomatic)	Phone interview	Patients with documented COVID-19 infection and NO symptoms
ROCCO-P (Pauci-symptomatic)	Phone interview	Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)
ROCCO-L (mild)	Phone interview	Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT
ROCCO-S(severe)	glycomic analysis	Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION

Primary Outcome Measures

Name	Time	Method
Glycomic profile as predictor of long-term morbidity	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

Trial Locations

Locations (1)

Aast Papa Giovanni Xxiii; 🇮🇹 Bergamo, Italy