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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Actual): 620

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • St. Claraspital AG - Department of Pulmonary Medicine
  • Bern, Switzerland, 3010
    • Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center
  • Fribourg, Switzerland, 1708
    • University and Hospital of Fribourg
  • Genève, Switzerland, 1211
    • Hôpitaux Universitaires de Genève - Service de Pneumologie
  • Lausanne, Switzerland, 1011
    • CHUV - Service de Pneumologie
  • Lugano, Switzerland, 6900
    • Clinica Moncucco
  • Sion, Switzerland, 1950
    • Hôpital du Valais - Service de Pneumologie
  • St. Gallen, Switzerland, 9007
    • Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich - Klinik für Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients included are survivors of COVID-19.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 Lung; COVID-19 survivors in Switzerland	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.; Other Names: Sampling biological material; Collection of health-related personal data

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; COVID-19; ARDS; Coronavirus infection; Lung abnormalities; Radiological abnormalities
• 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: 2020-00799

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