COVIDNCT04412460
Echocardiography in Patients With Covid-19
An observational study of COVID and ARDS, Human, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Prospective observational study of patients treated due to Covid-19 disease. Observation and analysis of echocardiographic studies performed in the intensive care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, ARDS, Human
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2020to 31 Dec 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: Adults admitted for ICU therapy due to severe Covid-19
Who may be able to join
- Age above 18 years
- Covid-19 disease
- invasive Ventilation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiography in Patients With Covid-19 Undergoing Intensive Care Therapy
Prospective observational study of patients treated due to Covid-19 disease. Observation and analysis of echocardiographic studies performed in the intensive care setting.
- Conditions
- COVID, ARDS, Human
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Measured: up to 90 days
Secondary outcomes (3)
ICU length-of stay
Measured: up to 90 days
ICU ventilator free days
Measured: up to 90 days
Hospital length-of-stay
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start20 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412460
- Sponsor's protocol ID
- CovidEcho
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography in Patients With Covid-19 Undergoing Intensive Care Therapy
- ClinicalTrials.gov ID
- NCT04412460
- Acronym / sponsor ID
- CovidEcho
- Conditions
- COVID, ARDS, Human
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Jun 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 study of patients treated due to Covid-19 disease. Observation and analysis of echocardiographic studies performed in the intensive care setting.
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
- Adults admitted for ICU therapy due to severe Covid-19
Key inclusion criteria (3 listed)
- Age above 18 years
- Covid-19 disease
- invasive Ventilation
Key exclusion criteria (1 listed)
- none
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
ICU Mortality
Time frame: up to 90 days
3 secondary outcomes
ICU length-of stay
Time frame: up to 90 days
ICU ventilator free days
Time frame: up to 90 days
Hospital length-of-stay
Time frame: up to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID and ARDS, Human, run by University Hospital Tuebingen 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Sep 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ICU Mortality (time frame: up to 90 days). 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 30 Sep 2021.