Long Term Outcomes in COVID-19 Patients Recruited in the CORIST Project

Sars-CoV-2 Infection Clinical Trial

— CORIST-2  

Official title:

Long Term Outcomes in COVID-19 Patients Recruited in the CORIST Project: Longitudinal Data and Case-control Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04907890
• Other study ID #: DEP_012021
• Status: Withdrawn
• Start date: June 14, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: September 2022
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Months after seemingly recovering from COVID-19, many patients continue to suffer from major long-term effects. Interestingly, the existence of direct link between the severity of the disease in its acute phase and the severity of the long-lasting symptoms is uncertain. We aim at characterizing the long term outcomes in patients hospitalised for COVID-19 including symptoms, medical history, persistent organ damage and neurological and behavioural sequelae.

Description:

The aims of this project are: 1) to estimate the degree of physical disability, including psychological sequelae, in survivors of COVID-19 >1-year post hospital discharge and how these long term effect are related to COVID-19 or Sars-Cov-2 infection; 2) to assess if a link between the severity or the treatment of the disease in its acute phase and the severity of the long-lasting symptoms exists. Aims will be accomplished by using data from the COVID-19 RISK and Treatments (CORIST) Project (ClinicalTrials.gov ID: NCT04318418). The CORIST study included N=4,396 patients hospitalized for SARS-Cov-2 infection in 35 hospitals across Italy, between February 2020 and May 2020. Within each participating hospital, clinical data were abstracted from electronic medical records. Collected data included patients' demographics, laboratory tests, medications in use, history of disease and prescribed pharmacological therapy for COVID-19 treatment. Information on the most severe manifestation of COVID-19 occurred during hospitalization was also captured. All survivor patients previously recruited in the CORIST study (N=3,648), will be reached by phone by the hospital in which they were healed for COVID-19, informed about the research objectives and procedure and, if they will accept to participate, they will ask to sign an institutional review board consent electronic form. Participants will be requested to return a series of web-based, validated questionnaires aimed at evaluating: 1) occurrence of COVID-19-related symptoms such as fatigue, dizziness, etc.; 2) behavioural features and modifications (e.g., disturbances in sleep, vision, hearing or olfaction); 3) neuropsychological evaluation, regarding multiple cognitive domains (e.g. memory domain, motivational factors, emotional state assessment, mood disturbance and quality of life); 4) change in dietary habits. Aim 1 Each participant ("case") will be asked to select two control subjects with the following characteristics: control1) same sex, ±5 years, who had a positive diagnosis for SARS-Cov-2 infection in the past (at least 6±2 months) and that was never hospitalised for COVID-19 as he/she had not severe symptoms and control2) same sex, ±5 years, who was never diagnosed for SARS-Cov-2 infection. Each accepting control will be asked to return similar (appropriately modified) questionnaires as cases. Comparisons of cases with control1 individuals will offer evidence of long-term effects due to severity of COVID-19, whereas contrasts of cases or control1 with control2 persons will give indication of long-term effects due to SARS-Cov-2 infection, irrespective from COVID-19. Aim 2 We expect that a large proportion of case patients has undergone a medical visit in the months after recovering by COVID-19, in the same hospital in which they were healed. For these patients, all available medical information (data on fibrosis, dyspnoea, thoracic pain, respiratory, cardiac, neurological and psychiatric diseases) gathered at follow-up visit will be collected. This bulk of information, together with that attained from questionnaires as described in aim 1 will be related to data (already available to us) from CORIST project and will allow test if a link between the severity or the management in hospital of the disease in its acute phase and the severity of the long-lasting symptoms exists.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

cases: survivor patients previously recruited in the CORIST study Exclusion Criteria: -

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Locations

Country	Name	City	State
Italy	IRCCS Neuromed, Department of Epidemiology and Prevention	Pozzilli

Sponsors (2)

Lead Sponsor	Collaborator
Neuromed IRCCS	Clinica Mediterranea

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Bonaccio M, Costanzo S, Ruggiero E, Persichillo M, Esposito S, Olivieri M, Di Castelnuovo A, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; Moli-LOCK Study Investigators. Changes in ultra-processed food consumption during the first Italian lockdown fo — View Citation

COVID-19 RISk and Treatments (CORIST) Collaboration. RAAS inhibitors are not associated with mortality in COVID-19 patients: Findings from an observational multicenter study in Italy and a meta-analysis of 19 studies. Vascul Pharmacol. 2020 Dec;135:106805 — View Citation

COVID-19 RISK and Treatments (CORIST) Collaboration. Use of hydroxychloroquine in hospitalised COVID-19 patients is associated with reduced mortality: Findings from the observational multicentre Italian CORIST study. Eur J Intern Med. 2020 Dec;82:38-47. d — View Citation

Di Castelnuovo A, Bonaccio M, Costanzo S, Gialluisi A, Antinori A, Berselli N, Blandi L, Bruno R, Cauda R, Guaraldi G, My I, Menicanti L, Parruti G, Patti G, Perlini S, Santilli F, Signorelli C, Stefanini GG, Vergori A, Abdeddaim A, Ageno W, Agodi A, Agos — View Citation

Di Castelnuovo A, Costanzo S, Antinori A, Berselli N, Blandi L, Bonaccio M, Cauda R, Guaraldi G, Menicanti L, Mennuni M, Parruti G, Patti G, Santilli F, Signorelli C, Vergori A, Abete P, Ageno W, Agodi A, Agostoni P, Aiello L, Al Moghazi S, Arboretti R, A — View Citation

Di Castelnuovo A, De Caterina R, de Gaetano G, Iacoviello L. Controversial Relationship Between Renin-Angiotensin System Inhibitors and Severity of COVID-19: Announcing a Large Multicentre Case-Control Study in Italy. Hypertension. 2020 Aug;76(2):312-313. — View Citation

Ruggiero E, Mignogna C, Costanzo S, Persichillo M, Di Castelnuovo A, Esposito S, Cerletti C, Donati MB, de Gaetano G, Iacoviello L, Bonaccio M; Moli-LOCK Study Investigators. Changes in the consumption of foods characterising the Mediterranean dietary pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical symptoms	Occurrence of COVID-19-related medical symptoms	1 year
Secondary	Difference between cases and controls in behavioural features as assessed by PHQ-9 Depression Test Questionnaire	Differences will be evaluated contrasting cases with both two types of controls and comparing the two groups of controls each other	1 year
Secondary	Difference between cases and controls in physicological features as assessed by GAD7 Anxiety Test Questionnaire	Differences will be evaluated contrasting cases with both two types of controls and comparing the two groups of controls each other	1 year
Secondary	Difference between cases and controls in physicological features as assessed by the Psychological resilience Test (CONNOR-DAVIDSON - 10 items)	Differences will be evaluated contrasting cases with both two types of controls and comparing the two groups of controls each other	1 year
Secondary	Difference between cases and controls in dietary habits as assessed by the mediterranean diet adherence score	Differences will be evaluated contrasting cases with both two types of controls and comparing the two groups of controls each other	1 year