Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19

Study Overview
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Brief Summary
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Prospective Observational Swiss Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19.

Detailed Description
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COVID-19 is a coronavirus induced viral pneumonia leading to Acute Respiratory Distress Syndrome. Previous coronavirus infections (SARS and MERS) led to pulmonary fibrosis in up to 30%. Prospective evaluation of lung abnormalities and pulmonary fibrosis after COVID-19 infection is crucial as novel treatments against lung fibrosis of different etiologies are available. No data on pulmonary longterm effects in COVID-19 survivors are currently available. The nation-wide Swiss COVID-19 lung group establishes a meticulously characterized prospective cohort study on pulmonary long-term sequela of patients living in Switzerland.

Official Title
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Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Other: COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. All adult patients with COVID-19 over 18 years. Exclusion Criteria: Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Lung<br>COVID-19 survivors in Switzerland | Other: COVID-19<br>* Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.<br>* Other names: Collection of health-related personal data;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary follow-up sequelae in patients after COVID-19 | Number of patients with the long-term pulmonary complications by measuring lung function, exercise testing and radiological Imaging | 36 months | 
| Evaluation of risk factors for adverse Outcome after COVID-19 | Number of patients with risk factors including comorbidities and other cofactors and correlate them to adverse outcome in patients after COVID-19 | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the functional Pulmonary outcome of COVID-19 disease | Compare pulmonary function measurements between mild and moderate to severe and critical COVID-19 disease | 36 months | 
| Compare the radiological Pulmonary outcome of COVID-19 disease | Compare imaging measurements between mild and moderate to severe and critical COVID-19 disease | 36 months | 
| Quality of Life after COVID-19 | Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease | 36 months | 
| Physical performance after COVID-19 using Clinical Frailty Scale | To observe and compare the physical performance after COVID-19 via the Clinical Frailty Scale between mild and moderate to severe and critical COVID-19 disease | 36 months | 
| Physical performance after COVID-19 using frailty assessment tests | To observe and compare the physical performance after COVID-19 via frailty assessment tests between mild and moderate to severe and critical COVID-19 disease | 36 months | 
| Microbiota and COVID-19 | Number of patients with changes in microbiota in response to COVID-19 by microbiota analysis of sputa, bronchoalveolar lavage and swaps | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, COVID-19, Coronavirus infection, Lung abnormalities, Radiological abnormalities, Quality of Life