COVID-19NCT04581135
Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
An observational study of COVID-19, run by Insel Gruppe AG, University Hospital Bern at 9 sites in Switzerland.
Trial summary
Prospective Observational Swiss Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19
- How many people
- 620 participants
- Where
- 9 sitesSwitzerland
- Study dates
- 1 May 2020to 30 Jan 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included are survivors of COVID-19.
Who may be able to join
- Signed written informed consent.
- All adult patients with COVID-19 over 18 years.
Who cannot join
- Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.
- Pregnancy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Switzerland9 sites
St. Claraspital AG - Department of Pulmonary Medicine
Basel, 4002
Universtiy Hospital Bern (Inselspital), Department of Pulmonary Medicine - Lead Center
Bern, 3010
University and Hospital of Fribourg
Fribourg, 1708
Hôpitaux Universitaires de Genève - Service de Pneumologie
Geneva, 1211
CHUV - Service de Pneumologie
Lausanne, 1011
Clinica Moncucco
Lugano, 6900
Kantonspital St. Gallen - Klinik für Pneumologie und Schlafmedizin Lungenzentrum
Sankt Gallen, 9007
Hôpital du Valais - Service de Pneumologie
Sion, 1950
Universitätsspital Zürich - Klinik für Pneumologie
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- COVID-19
- Keywords
- COVID-19, Coronavirus infection, Lung abnormalities, Radiological abnormalities, ARDS, Quality of Life
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
Also called Sampling biological material, Collection of health-related personal data
Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Lung | COVID-19 survivors in Switzerland Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 36 months
Secondary outcomes (6)
Compare the functional Pulmonary outcome of COVID-19 disease
Compare pulmonary function measurements between mild and moderate to severe and critical COVID-19 disease
Measured: 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
Measured: 36 months
Quality of Life after COVID-19
Compare Quality of Life questionnaires between mild and moderate to severe and critical COVID-19 disease
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 May 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 620 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Funke-Chambour, MD, Principal investigator, University Hospital Bern, Department of Pulmonary Medicine - Lead Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581135
- Sponsor's protocol ID
- 2020-00799
- Status last verified
- Mar 2023
- First submitted
- 17 Sep 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37789266
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19
- ClinicalTrials.gov ID
- NCT04581135
- Acronym / sponsor ID
- 2020-00799
- Conditions
- COVID-19
- Keywords
- COVID-19, Coronavirus infection, Lung abnormalities, Radiological abnormalities, ARDS, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Lung | – | Other: COVID-19COVID-19 survivors in Switzerland |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included are survivors of COVID-19.
Key inclusion criteria (2 listed)
- Signed written informed consent.
- All adult patients with COVID-19 over 18 years.
Key exclusion criteria (2 listed)
- Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19Also: Sampling biological material, Collection of health-related personal dataResearch project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used. | Other | COVID-19 Lung |
Primary outcome
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
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
6 secondary outcomes
Compare the functional Pulmonary outcome of COVID-19 disease
Time frame: 36 months
Compare the radiological Pulmonary outcome of COVID-19 disease
Time frame: 36 months
Quality of Life after COVID-19
Time frame: 36 months
Physical performance after COVID-19 using Clinical Frailty Scale
Time frame: 36 months
Physical performance after COVID-19 using frailty assessment tests
Time frame: 36 months
Microbiota and COVID-19
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 37789266Abu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Funke-Chambour, MD principal investigator
University Hospital Bern, Department of Pulmonary Medicine - Lead Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Insel Gruppe AG, University Hospital Bern at 9 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary follow-up sequelae in patients after COVID-19 (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.