Chronic PainROCCONCT04788433
Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients
An observational study of Chronic Pain and Morbidity, Multiple, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Morbidity, Multiple, Covid19
- What is being tested?
- glycomic analysis and Phone interview
- How many people
- 374 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2021to 10 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.
Who may be able to join
- Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
- Age >18 years
- Able to express informed consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and 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.
Read more
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.
- Conditions
- Chronic Pain, Morbidity, Multiple, Covid19
- Being tested
- glycomic analysis, Phone interview
- Medical subject headings
- Chronic Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycomic analysisDiagnostic test
Analysis of glycans on plasma samples
Phone interviewOther
patients are followed up by phone up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| ROCCO-A (A-symptomatic) | Patients with documented COVID-19 infection and NO symptoms Receives: Diagnostic Test: glycomic analysis; Other: Phone interview | |
| ROCCO-P (Pauci-symptomatic) | Patients with documented COVID-19 infection and mild symptoms but NO oxygen support) Receives: Diagnostic Test: glycomic analysis; Other: Phone interview | |
| ROCCO-L (mild) | Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT Receives: Diagnostic Test: glycomic analysis; Other: Phone interview | |
| ROCCO-M (moderate) | Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities Receives: Diagnostic Test: glycomic analysis; Other: Phone interview | |
| ROCCO-S(severe) | Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION Receives: Diagnostic Test: glycomic analysis; Other: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start4 Mar 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GENOS
- Responsible party
- Principal investigator, Dario Bugada, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788433
- Sponsor's protocol ID
- ROCCO-197/2020
- Acronym
- ROCCO
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04788433
- Acronym / sponsor ID
- ROCCO / ROCCO-197/2020
- Conditions
- Chronic Pain, Morbidity, Multiple, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Collaborators
- GENOS
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ROCCO-A (A-symptomatic) | – | Diagnostic Test: glycomic analysis, Other: Phone interviewPatients with documented COVID-19 infection and NO symptoms |
| ROCCO-P (Pauci-symptomatic) | – | Diagnostic Test: glycomic analysis, Other: Phone interviewPatients with documented COVID-19 infection and mild symptoms but NO oxygen support) |
| ROCCO-L (mild) | – | Diagnostic Test: glycomic analysis, Other: Phone interviewPatients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT |
| ROCCO-M (moderate) | – | Diagnostic Test: glycomic analysis, Other: Phone interviewPatients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities |
| ROCCO-S(severe) | – | Diagnostic Test: glycomic analysis, Other: Phone interviewPatients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
- Age >18 years
- Able to express informed consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glycomic analysisAnalysis of glycans on plasma samples | Diagnostic test | ROCCO-A (A-symptomatic), ROCCO-L (mild), ROCCO-M (moderate), ROCCO-P (Pauci-symptomatic), ROCCO-S(severe) |
| Phone interviewpatients are followed up by phone up to 1 year | Other | ROCCO-A (A-symptomatic), ROCCO-L (mild), ROCCO-M (moderate), ROCCO-P (Pauci-symptomatic), ROCCO-S(severe) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Morbidity, Multiple, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycomic profile as predictor of long-term morbidity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.