NCT04788433: ROCCO

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

Completed Last updated 4 April 2023

What this trial tests

trial testing glycomic analysis in Chronic Pain in 374 participants. Completed in 10 September 2022.

Timeline

4 March 2021

Primary endpoint
10 September 2021

10 September 2022

Quick facts

Lead sponsor	Papa Giovanni XXIII Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	374
Start date	4 March 2021
Primary completion	10 September 2021
Estimated completion	10 September 2022
Sites	1 location across Italy

Drugs / interventions tested

• glycomic analysis
• Phone interview

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Morbidity, Multiple — all drugs for Morbidity, Multiple →
• Covid19 — all drugs for Covid19 →

Sponsor

Papa Giovanni XXIII Hospital

Who can join

18 and older, any sex, with Chronic Pain or Morbidity, Multiple. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Chronic pain and infection: mechanisms, causes, conditions, treatments, and controversies.
   Cohen SP, Wang EJ, Doshi TL, Vase L, et al · · 2022 · cited 42× · PMID 36936554 · DOI 10.1136/bmjmed-2021-000108