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OpenTrials
Completed

NCT Number: NCT04788433

Registry of Coronavirus Complications - 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glycomic analysis

Diagnostic Test

Analysis of glycans on plasma samples

Phone Interview

Other

patients are followed up by phone up to 1 year

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Collaborators

  • GENOS

Registry information

Official study title

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

Acronym: ROCCO

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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