SARS-CoV 2NCT04365595
SARS-CoV-2 Associated Respiratory Failure Recovery (COVID-19 CAir)
An observational study of SARS-CoV 2 and COVID, run by University of Zurich at 1 site in Switzerland.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2, COVID
- What is being tested?
- Questionnaires, spirometry
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jun 2020to 17 Feb 2021
- 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 with SARS-CoV-2 associated respiratory failure
Who may be able to join
- hospitalization at University Hospital Zurich due to COVID-19 infection
- hospital discharge max. 4 weeks ago
- requiring supplemental oxygen
Who cannot join
- <18 years
- non-German speaking
- no smartphone access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.
Read the detailed description
Study aims:
- To evaluate subjective and objective recovery after discharge from hospital in patients with respiratory failure due to COVID-19.
- To identify risk factors for COVID-19 associated respiratory failure and prolonged recovery
- Conditions
- SARS-CoV 2, COVID
- Being tested
- Questionnaires, spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, spirometryOther
Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 associated respiratory failure | Participants will receive a daily HrQoL questionnaire on their personal smartphone using the docdok health application during 3 months. A selection of participants will furthermore receive a custom-built home disease monitoring device during 1 month. Both procedures start at least 4 weeks after hospital discharge. Receives: Other: Questionnaires, spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality-of-life
European Quality of Life - 5 Dimensions - 5 Levels Instrument (EQ-5D-5L). Scoring: Index ranges from 1 to <0, with lower scores indicating more limitations.
Measured: 3 months
Secondary outcomes (4)
Anxiety and depression
Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.
Measured: 3 months
Symptom burden
COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.
Measured: 3 months
Spirometry
Forced expiratory volume in one second (FEV1) in liters and percent predicted.
Measured: 1 month
Spirometry
Forced vital capacity (FVC) in liters and percent predicted.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start3 Jun 2020
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
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 SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian F Clarenbach, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365595
- Sponsor's protocol ID
- 2020-00745
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: on reasonable request
Publications
Kohlbrenner D, Kuhn M, Stussi-Helbling M, Nordmann Y, Spielmanns M, Clarenbach CF. Longitudinal Smartphone-Based Post-hospitalisation Symptom Monitoring in SARS-CoV-2 Associated Respiratory Failure: A Multi-Centre Observational Study. Front Rehabil Sci. 2021 Nov 24;2:777396. doi: 10.3389/fresc.2021.777396. eCollection 2021.
PubMed 36188784
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure
- ClinicalTrials.gov ID
- NCT04365595
- Acronym / sponsor ID
- 2020-00745
- Conditions
- SARS-CoV 2, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 28 Apr 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.
Detailed description
Study aims:
- To evaluate subjective and objective recovery after discharge from hospital in patients with respiratory failure due to COVID-19.
- To identify risk factors for COVID-19 associated respiratory failure and prolonged recovery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 associated respiratory failure | – | Other: Questionnaires, spirometryParticipants will receive a daily HrQoL questionnaire on their personal smartphone using the docdok health application during 3 months. A selection of participants will furthermore receive a custom-built home disease monitoring device during 1 month. Both procedures start at least 4 weeks after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SARS-CoV-2 associated respiratory failure
Key inclusion criteria (3 listed)
- hospitalization at University Hospital Zurich due to COVID-19 infection
- hospital discharge max. 4 weeks ago
- requiring supplemental oxygen
Key exclusion criteria (3 listed)
- <18 years
- non-German speaking
- no smartphone access
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 |
|---|---|---|
| Questionnaires, spirometryQuestionnaires targeting health-related quality-of-life, symptoms, anxiety and depression | Other | SARS-CoV-2 associated respiratory failure |
Primary outcome
Health-related quality-of-life
Time frame: 3 months
European Quality of Life - 5 Dimensions - 5 Levels Instrument (EQ-5D-5L). Scoring: Index ranges from 1 to <0, with lower scores indicating more limitations.
4 secondary outcomes
Anxiety and depression
Time frame: 3 months
Symptom burden
Time frame: 3 months
Spirometry
Time frame: 1 month
Spirometry
Time frame: 1 month
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 23 Feb 2021.
- Derived from this study: PubMed 36188784Kohlbrenner D, Kuhn M, Stussi-Helbling M, Nordmann Y, Spielmanns M, Clarenbach CF. Longitudinal Smartphone-Based Post-hospitalisation Symptom Monitoring in SARS-CoV-2 Associated Respiratory Failure: A Multi-Centre Observational Study. Front Rehabil Sci. 2021 Nov 24;2:777396. doi: 10.3389/fresc.2021.777396. eCollection 2021.
- Individual participant dataSharing planned: Undecided. on reasonable request
Related trials for SARS-CoV 2
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
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.
Christian F Clarenbach, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 and COVID, run by University of Zurich at 1 site 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 3 inclusion and 3 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Health-related quality-of-life (time frame: 3 months). 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 NCT04365595, 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 23 Feb 2021.