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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581135
• Other study ID #: 2020-00799
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• COVID-19
Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.

Locations

Country	Name	City	State
Switzerland	St. Claraspital AG - Department of Pulmonary Medicine	Basel
Switzerland	Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center	Bern
Switzerland	University and Hospital of Fribourg	Fribourg
Switzerland	Hôpitaux Universitaires de Genève - Service de Pneumologie	Genève
Switzerland	CHUV - Service de Pneumologie	Lausanne
Switzerland	Clinica Moncucco	Lugano
Switzerland	Hôpital du Valais - Service de Pneumologie	Sion
Switzerland	Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum	St. Gallen
Switzerland	Universitätsspital Zürich - Klinik für Pneumologie	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Quality of Life after COVID-19	Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease	36 months
Secondary	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
Secondary	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
Secondary	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