NCT04788433

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 7, 2021

Last Update Submit

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

Diagnostic Test: glycomic analysisOther: Phone interview

ROCCO-P (Pauci-symptomatic)

Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)

Diagnostic Test: glycomic analysisOther: Phone interview

ROCCO-L (mild)

Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT

Diagnostic Test: glycomic analysisOther: Phone interview

ROCCO-M (moderate)

Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities

Diagnostic Test: glycomic analysisOther: Phone interview

ROCCO-S(severe)

Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION

Diagnostic Test: glycomic analysisOther: Phone interview

Interventions

glycomic analysisDIAGNOSTIC_TEST

Analysis of glycans on plasma samples

ROCCO-A (A-symptomatic)ROCCO-L (mild)ROCCO-M (moderate)ROCCO-P (Pauci-symptomatic)ROCCO-S(severe)

patients are followed up by phone up to 1 year

ROCCO-A (A-symptomatic)ROCCO-L (mild)ROCCO-M (moderate)ROCCO-P (Pauci-symptomatic)ROCCO-S(severe)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Aast Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

Chronic PainCOVID-19

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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

Locations