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
1 other identifier
observational
374
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2021
CompletedFirst Submitted
Initial submission to the registry
March 7, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2022
CompletedApril 4, 2023
March 1, 2023
6 months
March 7, 2021
March 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (5)
ROCCO-A (A-symptomatic)
Patients with documented COVID-19 infection and NO symptoms
ROCCO-P (Pauci-symptomatic)
Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)
ROCCO-L (mild)
Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT
ROCCO-M (moderate)
Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities
ROCCO-S(severe)
Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION
Interventions
Analysis of glycans on plasma samples
patients are followed up by phone up to 1 year
Eligibility Criteria
Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.
You may qualify if:
- Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
- Age \>18 years
- Able to express informed consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Papa Giovanni XXIII Hospitallead
- GENOScollaborator
Study Sites (1)
Aast Papa Giovanni Xxiii
Bergamo, 24127, Italy
Biospecimen
plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
March 7, 2021
First Posted
March 9, 2021
Study Start
March 4, 2021
Primary Completion
September 10, 2021
Study Completion
September 10, 2022
Last Updated
April 4, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share