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

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ClinicalTrials.gov Identifier: NCT04581135
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment
COVID-19 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pulmonary follow-up sequelae in patients after COVID-19 [ Time Frame: 36 months ]
    Number of patients with the long-term pulmonary complications by measuring lung function, exercise testing and radiological Imaging

  2. Evaluation of risk factors for adverse Outcome after COVID-19 [ Time Frame: 36 months ]
    Number of patients with risk factors including comorbidities and other cofactors and correlate them to adverse outcome in patients after COVID-19


Secondary Outcome Measures :
  1. Compare the functional Pulmonary outcome of COVID-19 disease [ Time Frame: 36 months ]
    Compare pulmonary function measurements between mild and moderate to severe and critical COVID-19 disease

  2. Compare the radiological Pulmonary outcome of COVID-19 disease [ Time Frame: 36 months ]
    Compare imaging measurements between mild and moderate to severe and critical COVID-19 disease

  3. Quality of Life after COVID-19 [ Time Frame: 36 months ]
    Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease

  4. Physical performance after COVID-19 using Clinical Frailty Scale [ Time Frame: 36 months ]
    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

  5. Physical performance after COVID-19 using frailty assessment tests [ Time Frame: 36 months ]
    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

  6. Microbiota and COVID-19 [ Time Frame: 36 months ]
    Number of patients with changes in microbiota in response to COVID-19 by microbiota analysis of sputa, bronchoalveolar lavage and swaps


Biospecimen Retention:   Samples Without DNA
Coded biological material

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients included are survivors of COVID-19.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581135


Contacts
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Contact: Manuela Funke-Chambour, MD +4131 632 21 11 Manuela.Funke-Chambour@insel.ch

Locations
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Switzerland
St. Claraspital AG - Department of Pulmonary Medicine Recruiting
Basel, Switzerland, 4002
Contact: Sebastian R. Ott, PD         
Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center Recruiting
Bern, Switzerland, 3010
Contact: Manuela Funke-Chambour, PD    +41316322111 ext +41316322111    Manuela.Funke-Chambour@insel.ch   
Contact: Kurt De Jaegere    +41316322111    kurt.dejaegere@insel.ch   
University and Hospital of Fribourg Recruiting
Fribourg, Switzerland, 1708
Contact: Marco Mancinetti, MD         
Hôpitaux Universitaires de Genève - Service de Pneumologie Recruiting
Genève, Switzerland, 1211
Contact: Paola Gasche Soccal, Prof.         
CHUV - Service de Pneumologie Recruiting
Lausanne, Switzerland, 1011
Contact: Christophe von Garnier, Prof.         
Clinica Moncucco Recruiting
Lugano, Switzerland, 6900
Contact: Christian Garzoni, PD         
Hôpital du Valais - Service de Pneumologie Recruiting
Sion, Switzerland, 1950
Contact: Pierre-Olivier Bridevaux, Prof.         
Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum Recruiting
St. Gallen, Switzerland, 9007
Contact: Martin Brutsche, Prof.         
Universitätsspital Zürich - Klinik für Pneumologie Recruiting
Zürich, Switzerland, 8091
Contact: Christian Clarenbach, PD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Manuela Funke-Chambour, MD University Hospital Bern, Department of Pulmonary Medicine - Lead Center
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04581135    
Other Study ID Numbers: 2020-00799
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
COVID-19
Coronavirus infection
Lung abnormalities
 Radiological abnormalities
ARDS
Quality of Life
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases