SARS-CoV2CROWNLESSNCT04456075
Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
An observational study of SARS-CoV2 and COVID, run by Heidelberg University at 1 site in Germany.
Trial summary
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to Apr 2022
- 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 infection / COVID 19
Who may be able to join
- SARS-CoV-2 infection / COVID 19
Who cannot join
- invasive ventilation
- respiratory failure at admission
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik at Heidelberg University
Heidelberg, 69126
Frederik Trinkmann, MD, + 49 6221 396 ext. 1201, frederik.trinkmann@med.uni-heidelberg.de
About this study
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
TLCO
Transfer factor for carbon monoxide
Measured: 3-5 days intervals (inpatients)
TLCO
Transfer factor for carbon monoxide
Measured: 1-6 months (outpatients, follow up)
D5-20
frequency dependence of resistance as measured by oscillometry
Measured: 3-5 days intervals (inpatients
D5-20
frequency dependence of resistance as measured by oscillometry
Measured: 1-6 months (outpatients, follow up)
FEV1/FVC
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
Measured: 3-5 days intervals (inpatients)
FEV1/FVC
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
Measured: 1-6 months (outpatients, follow up)
Secondary outcomes (3)
comorbidities
structured questionnaire
Measured: at hospital admission and each follow (every 1-6 months)
clinical symptoms
structured qualitative questionnaire
Measured: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
St. George's Respiratory Questionnaire total score
validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)
Measured: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Apr 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Heidelberg University
- Investigators
- Frederik Trinkmann, MD, Principal investigator, Thoraxklinik at Heidelberg UniversityFelix JF Herth, MD, Study director, Thoraxklinik at Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456075
- Sponsor's protocol ID
- CROWNLESS
- Acronym
- CROWNLESS
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
- ClinicalTrials.gov ID
- NCT04456075
- Acronym / sponsor ID
- CROWNLESS / CROWNLESS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 2 Jul 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.
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 infection / COVID 19
Key inclusion criteria (1 listed)
- SARS-CoV-2 infection / COVID 19
Key exclusion criteria (2 listed)
- invasive ventilation
- respiratory failure at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TLCO
Time frame: 3-5 days intervals (inpatients)
Transfer factor for carbon monoxide
TLCO
Time frame: 1-6 months (outpatients, follow up)
Transfer factor for carbon monoxide
D5-20
Time frame: 3-5 days intervals (inpatients
frequency dependence of resistance as measured by oscillometry
D5-20
Time frame: 1-6 months (outpatients, follow up)
frequency dependence of resistance as measured by oscillometry
FEV1/FVC
Time frame: 3-5 days intervals (inpatients)
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
FEV1/FVC
Time frame: 1-6 months (outpatients, follow up)
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
3 secondary outcomes
comorbidities
Time frame: at hospital admission and each follow (every 1-6 months)
clinical symptoms
Time frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
St. George's Respiratory Questionnaire total score
Time frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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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.
Frederik Trinkmann, MD principal investigator
Thoraxklinik at Heidelberg University
Felix JF Herth, MD study director
Thoraxklinik at Heidelberg University
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-CoV2 and COVID, run by Heidelberg University at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Jul 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Trinkmann, MD (+49 6221 396 ext. 1201, frederik.trinkmann@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLCO (time frame: 3-5 days intervals (inpatients)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2020.