Clinical trial NCT04907890: Long Term Outcomes in COVID-19 Patients Recruited in the CORIST Project
Official title: Long Term Outcomes in COVID-19 Patients Recruited in the CORIST Project: Longitudinal Data and Case-control Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sars-CoV-2 Infection
Long Covid19
Keywords: Sars-CoV-2
Long Covid19
Case-control study
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
Collaborators: name: Clinica Mediterranea
First posted: 2021-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

cases: survivor patients previously recruited in the CORIST study

Exclusion Criteria:

-

Primary outcomes:
measure: Medical symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Difference between cases and controls in behavioural features as assessed by PHQ-9 Depression Test Questionnaire
timeFrame: 1 year
measure: Difference between cases and controls in physicological features as assessed by GAD7 Anxiety Test Questionnaire
timeFrame: 1 year
measure: Difference between cases and controls in physicological features as assessed by the Psychological resilience Test (CONNOR-DAVIDSON - 10 items)
timeFrame: 1 year
measure: Difference between cases and controls in dietary habits as assessed by the mediterranean diet adherence score
timeFrame: 1 year
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed, Department of Epidemiology and Prevention
Study officials:
References:
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. doi: 10.1016/j.ejim.2020.08.019. Epub 2020 Aug 25.
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