Long Term Outcomes in COVID-19 Patients Recruited in the CORIST Project (CORIST-2)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Long Covid19; Sars-CoV-2 Infection

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Italy
  • Pozzilli, Italy, 86077
    • IRCCS Neuromed, Department of Epidemiology and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases: survivor patients previously recruited in the CORIST study Each 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 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

Description

Inclusion Criteria:

cases: survivor patients previously recruited in the CORIST study

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cases; All survivor patients hospitalised for COVID-19 and previously recruited in the CORIST study
Controls 1; Individuals who had a positive diagnosis for SARS-Cov-2 infection in the past (at least 6 months) and that was never hospitalised for COVID-19 as he/she had not severe symptoms.
Controls 2; Individuals who was never diagnosed for SARS-Cov-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical symptoms	Occurrence of COVID-19-related medical symptoms	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Neuromed IRCCS
• Collaborators: Clinica Mediterranea

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.ejim.2020.08.019. Epub 2020 Aug 25.
• 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, Agostoni P, Aiello L, Al Moghazi S, Aucella F, Barbieri G, Bartoloni A, Bologna C, Bonfanti P, Brancati S, Cacciatore F, Caiano L, Cannata F, Carrozzi L, Cascio A, Cingolani A, Cipollone F, Colomba C, Crisetti A, Crosta F, Danzi GB, D'Ardes D, de Gaetano Donati K, Di Gennaro F, Di Palma G, Di Tano G, Fantoni M, Filippini T, Fioretto P, Fusco FM, Gentile I, Grisafi L, Guarnieri G, Landi F, Larizza G, Leone A, Maccagni G, Maccarella S, Mapelli M, Maragna R, Marcucci R, Maresca G, Marotta C, Marra L, Mastroianni F, Mengozzi A, Menichetti F, Milic J, Murri R, Montineri A, Mussinelli R, Mussini C, Musso M, Odone A, Olivieri M, Pasi E, Petri F, Pinchera B, Pivato CA, Pizzi R, Poletti V, Raffaelli F, Ravaglia C, Righetti G, Rognoni A, Rossato M, Rossi M, Sabena A, Salinaro F, Sangiovanni V, Sanrocco C, Scarafino A, Scorzolini L, Sgariglia R, Simeone PG, Spinoni E, Torti C, Trecarichi EM, Vezzani F, Veronesi G, Vettor R, Vianello A, Vinceti M, De Caterina R, Iacoviello L; COvid-19 RISk and Treatments (CORIST) collaboration. Common cardiovascular risk factors and in-hospital mortality in 3,894 patients with COVID-19: survival analysis and machine learning-based findings from the multicentre Italian CORIST Study. Nutr Metab Cardiovasc Dis. 2020 Oct 30;30(11):1899-1913. doi: 10.1016/j.numecd.2020.07.031. Epub 2020 Jul 31.
• 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, Astuto M, Aucella F, Barbieri G, Bartoloni A, Bonfanti P, Cacciatore F, Caiano L, Carrozzi L, Cascio A, Ciccullo A, Cingolani A, Cipollone F, Colomba C, Colombo C, Crosta F, Danzi GB, D'Ardes D, de Gaetano Donati K, Di Gennaro F, Di Tano G, D'Offizi G, Fantoni M, Fusco FM, Gentile I, Gianfagna F, Grandone E, Graziani E, Grisafi L, Guarnieri G, Larizza G, Leone A, Maccagni G, Madaro F, Maitan S, Mancarella S, Mapelli M, Maragna R, Marcucci R, Maresca G, Marongiu S, Marotta C, Marra L, Mastroianni F, Mazzitelli M, Mengozzi A, Menichetti F, Meschiari M, Milic J, Minutolo F, Molena B, Montineri A, Mussini C, Musso M, Niola D, Odone A, Olivieri M, Palimodde A, Parisi R, Pasi E, Pesavento R, Petri F, Pinchera B, Poletti V, Ravaglia C, Rognoni A, Rossato M, Rossi M, Sangiovanni V, Sanrocco C, Scorzolini L, Sgariglia R, Simeone PG, Taddei E, Torti C, Vettor R, Vianello A, Vinceti M, Virano A, Vocciante L, De Caterina R, Iacoviello L. Heparin in COVID-19 Patients Is Associated with Reduced In-Hospital Mortality: The Multicenter Italian CORIST Study. Thromb Haemost. 2021 Aug;121(8):1054-1065. doi: 10.1055/a-1347-6070. Epub 2021 Feb 28.
• 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. doi: 10.1016/j.vph.2020.106805. Epub 2020 Sep 28.
• 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. doi: 10.1161/HYPERTENSIONAHA.120.15370. Epub 2020 May 8. No abstract available.
• 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 pattern and major correlates during the COVID-19 confinement in Italy: results from two cohort studies. Int J Food Sci Nutr. 2021 Dec;72(8):1105-1117. doi: 10.1080/09637486.2021.1895726. Epub 2021 Apr 6.
• 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 following the COVID-19 pandemic and major correlates: results from two population-based cohorts. Public Health Nutr. 2021 Aug;24(12):3905-3915. doi: 10.1017/S1368980021000999. Epub 2021 Mar 5.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 14, 2022
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sars-CoV-2; Case-control study; Long Covid19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DEP_012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No