Clinical trial NCT04581135: Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
Official title: Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Coronavirus infection
Lung abnormalities
Radiological abnormalities
ARDS
Quality of Life
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included are survivors of COVID-19.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary follow-up sequelae in patients after COVID-19
timeFrame: 36 months
measure: Evaluation of risk factors for adverse Outcome after COVID-19
timeFrame: 36 months
Secondary outcomes:
measure: Compare the functional Pulmonary outcome of COVID-19 disease
timeFrame: 36 months
measure: Compare the radiological Pulmonary outcome of COVID-19 disease
timeFrame: 36 months
measure: Quality of Life after COVID-19
timeFrame: 36 months
measure: Physical performance after COVID-19 using Clinical Frailty Scale
timeFrame: 36 months
measure: Physical performance after COVID-19 using frailty assessment tests
timeFrame: 36 months
measure: Microbiota and COVID-19
timeFrame: 36 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital AG - Department of Pulmonary Medicine
city: Bern
country: Switzerland
facility: Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center
city: Fribourg
country: Switzerland
facility: University and Hospital of Fribourg
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève - Service de Pneumologie
city: Lausanne
country: Switzerland
facility: CHUV - Service de Pneumologie
city: Lugano
country: Switzerland
facility: Clinica Moncucco
city: Sion
country: Switzerland
facility: Hôpital du Valais - Service de Pneumologie
city: St. Gallen
country: Switzerland
facility: Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich - Klinik für Pneumologie
Study officials:
affiliation: University Hospital Bern, Department of Pulmonary Medicine - Lead Center
name: Manuela Funke-Chambour, MD
role: PRINCIPAL_INVESTIGATOR
References: