NCT04581135

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

September 17, 2020

Last Update Submit

March 13, 2023

Conditions

COVID-19

Keywords

COVID-19Coronavirus infectionLung abnormalitiesRadiological abnormalitiesARDSQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Compare the functional Pulmonary outcome of COVID-19 disease

    36 months

  • Compare the radiological Pulmonary outcome of COVID-19 disease

    36 months

  • Quality of Life after COVID-19

    36 months

  • Physical performance after COVID-19 using Clinical Frailty Scale

    36 months

  • Physical performance after COVID-19 using frailty assessment tests

    36 months

  • +1 more secondary outcomes

Study Arms (1)

COVID-19 Lung

COVID-19 survivors in Switzerland

Other: COVID-19

Interventions

COVID-19OTHER

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

Also known as: Sampling biological material, Collection of health-related personal data
COVID-19 Lung

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients included are survivors of COVID-19.

You may qualify if:

  • Signed written informed consent.
  • All adult patients with COVID-19 over 18 years.

You may not qualify if:

  • Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

St. Claraspital AG - Department of Pulmonary Medicine

Basel, 4002, Switzerland

Location

Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center

Bern, 3010, Switzerland

Location

University and Hospital of Fribourg

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires de Genève - Service de Pneumologie

Geneva, 1211, Switzerland

Location

CHUV - Service de Pneumologie

Lausanne, 1011, Switzerland

Location

Clinica Moncucco

Lugano, 6900, Switzerland

Location

Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum

Sankt Gallen, 9007, Switzerland

Location

Hôpital du Valais - Service de Pneumologie

Sion, 1950, Switzerland

Location

Universitätsspital Zürich - Klinik für Pneumologie

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Abu Hussein N, Machahua C, Ruchti SC, Horn MP, Piquilloud L, Prella M, Geiser TK, von Garnier C, Funke-Chambour M. Circulating calprotectin levels four months after severe and non-severe COVID-19. BMC Infect Dis. 2023 Oct 3;23(1):650. doi: 10.1186/s12879-023-08653-7.

    PMID: 37789266DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Coded biological material

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manuela Funke-Chambour, MD

    University Hospital Bern, Department of Pulmonary Medicine - Lead Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2020

First Posted

October 9, 2020

Study Start

May 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

CH(9)