COVID-19NCT04527497
Clinical Course and Treatment of COVID-19 Inpatients in Hospital
An observational study of COVID-19, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 31 Aug 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
- Adult, Older adult
Study population: All patients who are inpatients at Bethanien Hospital and have a proven COVID-19 infection and who agree to participate in the study during the period from 01.08.2020 - 30.05.2021.
Who may be able to join
- positive COVID-19 test result
- Age > 18 years
Who cannot join
- Age < 18 years
- negative COVID-19 test result
- lack of agreement
- Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.
Read the detailed description
The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients:
- Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease?
- Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
convalescence/death
has patient died or has patient recovered
Measured: through study completion, an average of 2 months
Secondary outcomes (2)
length of stay in the intensive care unit
length of stay in the intensive care unit
Measured: through study completion, an average of 2 months
length of stay in hospital
length of stay in hospital
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Aug 2020
- Primary completion30 May 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Randerath, Prof. Dr., Principal investigator, Krankenhaus Bethanien Solingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527497
- Sponsor's protocol ID
- WI_20-1294
- Status last verified
- Oct 2021
- First submitted
- 20 Aug 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course and Treatment of COVID-19 Inpatients in Hospital
- ClinicalTrials.gov ID
- NCT04527497
- Acronym / sponsor ID
- WI_20-1294
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 26 Aug 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.
The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.
Detailed description
The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients:
- Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease?
- Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who are inpatients at Bethanien Hospital and have a proven COVID-19 infection and who agree to participate in the study during the period from 01.08.2020 - 30.05.2021.
Key inclusion criteria (2 listed)
- positive COVID-19 test result
- Age > 18 years
Key exclusion criteria (4 listed)
- Age < 18 years
- negative COVID-19 test result
- lack of agreement
- Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial
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
convalescence/death
Time frame: through study completion, an average of 2 months
has patient died or has patient recovered
2 secondary outcomes
length of stay in the intensive care unit
Time frame: through study completion, an average of 2 months
length of stay in hospital
Time frame: through study completion, an average of 2 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 15 Dec 2023.
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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.
Winfried Randerath, Prof. Dr. principal investigator
Krankenhaus Bethanien Solingen
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-19, run by Wissenschaftliches Institut Bethanien e.V 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 2 inclusion and 4 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 15 Dec 2023. 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 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?
convalescence/death (time frame: through study completion, an average of 2 months). 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 15 Dec 2023.