COVID-19NCT04344171
CovidDB: The Covid-19 Inpatient Database
An observational study of COVID-19, run by ClarData at 9 sites in 2 countries.
Trial summary
The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 5,000 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 30 Mar 2020to 30 Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study is focused on all Covid-19 inpatients which are treated in the recruited hospitals.
Who may be able to join
- Covid-19 inpatients
Who cannot join
- assumed Covid-19 patient
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites, 8 recruiting
- Recruiting
RoMed - Klinikum Bad Aibling
Bad Aibling
Stefan Budweiser, Prof.
- Not yet recruiting
DONAUISAR Klinikum Deggendorf
Deggendorf
Adi Kovacevic, Dr.
- Not yet recruiting
DONAUISAR Klinikum Dingolfing
Dingolfing
Heribert Fröschl, Dr.
- Recruiting
RoMed - Klinikum Prien am Chiemsee
Prien am Chiemsee
Stefan Budweiser, Prof.
- Recruiting
RoMed - Klinikum Rosenheim
Rosenheim
Stefan Budweiser, Prof.
- Recruiting
Universitätsklinikum Ulm
Ulm
Thomas Seufferlein, Prof
- Recruiting
RoMed - Klinikum Wasserburg Am Inn
Wasserburg am Inn
Stefan Budweiser, Prof.
- Recruiting
Klinikum Altmühlfranken
Weißenburg
Marius Ghidau, Dr.
Romania1 site, 1 recruiting
- Recruiting
Timiş County Emergency Clinical Hospital
Timișoara
Ovidiu Bedreag, Prof.
About this study
The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.
Read the detailed description
The exponentially increasing number of SARS-CoV-2 infected people, despite the influence of the currently existing non-medical measures, is generating a rapidly increasing number of inpatients, some of whom need artificial ventilation. The average focus is on the extent to which the hospitals' capacities will be sufficient to adequately treat all patients. Regardless of this, it can be expected that even if the non-medical measures are successful, the number of inpatients treated will remain high in the course of the pandemic. With regard to the distribution of infection, it can be expected that clinics with a wide range of expertise will have to treat a large number of Covid-19 patients.
So far, however, there is little to no experience in treating patients. In addition to epidemiological data, only case descriptions and some Chinese studies mostly from Wuhan based on fewer patients are available. In view of the rapidly spreading pandemic, preprints are increasingly being used. What has been missing so far is a uniform, structured recording of the courses of Covid-19 inpatients handled by many clinics, which goes beyond the epidemiological events in terms of depth of detail. With this documentation of real processes, the basis for a large number of studies and the associated better understanding of the disease process could be created.
The current dynamics make it imperative that the clinics, even those who have not received the most up-to-date scientific knowledge, cannot wait for the results of studies, but rather need concrete help in the treatment of patients. Efficient assistance within the framework of a close exchange between the treatment units is only possible with a multicentre, uniform documentation environment.
The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.
- Conditions
- COVID-19
- Keywords
- Sars-Cov-2, Covid-19, antiviral therapy, ventilation, ECMO
- Medical subject headings
- COVID-19, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome comparison between different antiviral therapies
Different antivirals and their combinations will be tested and the outcome (cured/deceased) will be assessed
Measured: through study completion, an average of 1 year
Outcome comparisons between ventilation types
Different ventilation types will be tested and the outcome (cured/deceased) will be assessed
Measured: through study completion, an average of 1 year
Identification of risk factors
Clinical and laboratory risk factors will be recorded and the outcome (cured/deceased) will be assessed
Measured: through study completion, an average of 1 year
Number of days in hospital vs. clinical classification
Correlation between number of days in hospital and worst clinical classification will be calculated
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start30 Mar 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
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.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClarData
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Ferencz, MD, Principal investigator, ClarDataHans-Rudolf Tinneberg, Prof., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344171
- Sponsor's protocol ID
- CovidDB
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Budweiser S, Bas S, Jorres RA, Engelhardt S, von Delius S, Lenherr K, Deerberg-Wittram J, Bauer A. Patients' treatment limitations as predictive factor for mortality in COVID-19: results from hospitalized patients of a hotspot region for SARS-CoV-2 infections. Respir Res. 2021 Jun 4;22(1):168. doi: 10.1186/s12931-021-01756-2.
PubMed 34098967
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CovidDB: The Covid-19 Inpatient Database
- ClinicalTrials.gov ID
- NCT04344171
- Acronym / sponsor ID
- CovidDB
- Conditions
- COVID-19
- Keywords
- Sars-Cov-2, Covid-19, antiviral therapy, ventilation, ECMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- ClarDataUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 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.
The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.
Detailed description
The exponentially increasing number of SARS-CoV-2 infected people, despite the influence of the currently existing non-medical measures, is generating a rapidly increasing number of inpatients, some of whom need artificial ventilation. The average focus is on the extent to which the hospitals' capacities will be sufficient to adequately treat all patients. Regardless of this, it can be expected that even if the non-medical measures are successful, the number of inpatients treated will remain high in the course of the pandemic. With regard to the distribution of infection, it can be expected that clinics with a wide range of expertise will have to treat a large number of Covid-19 patients.
So far, however, there is little to no experience in treating patients. In addition to epidemiological data, only case descriptions and some Chinese studies mostly from Wuhan based on fewer patients are available. In view of the rapidly spreading pandemic, preprints are increasingly being used. What has been missing so far is a uniform, structured recording of the courses of Covid-19 inpatients handled by many clinics, which goes beyond the epidemiological events in terms of depth of detail. With this documentation of real processes, the basis for a large number of studies and the associated better understanding of the disease process could be created.
The current dynamics make it imperative that the clinics, even those who have not received the most up-to-date scientific knowledge, cannot wait for the results of studies, but rather need concrete help in the treatment of patients. Efficient assistance within the framework of a close exchange between the treatment units is only possible with a multicentre, uniform documentation environment.
The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study is focused on all Covid-19 inpatients which are treated in the recruited hospitals.
Key inclusion criteria (1 listed)
- Covid-19 inpatients
Key exclusion criteria (1 listed)
- assumed Covid-19 patient
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
Outcome comparison between different antiviral therapies
Time frame: through study completion, an average of 1 year
Different antivirals and their combinations will be tested and the outcome (cured/deceased) will be assessed
Outcome comparisons between ventilation types
Time frame: through study completion, an average of 1 year
Different ventilation types will be tested and the outcome (cured/deceased) will be assessed
Identification of risk factors
Time frame: through study completion, an average of 1 year
Clinical and laboratory risk factors will be recorded and the outcome (cured/deceased) will be assessed
Number of days in hospital vs. clinical classification
Time frame: through study completion, an average of 1 year
Correlation between number of days in hospital and worst clinical classification will be calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 34098967Budweiser S, Bas S, Jorres RA, Engelhardt S, von Delius S, Lenherr K, Deerberg-Wittram J, Bauer A. Patients' treatment limitations as predictive factor for mortality in COVID-19: results from hospitalized patients of a hotspot region for SARS-CoV-2 infections. Respir Res. 2021 Jun 4;22(1):168. doi: 10.1186/s12931-021-01756-2.
- This is the website of the study and databaseLink provided by the sponsor.
- 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.
Julia Ferencz, MD principal investigator
ClarData
Hans-Rudolf Tinneberg, Prof. principal investigator
University of Giessen
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by ClarData at 9 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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 Germany, Romania. 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 Julia Ferencz, MD (+4917687607223, j.ferencz@clardata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome comparison between different antiviral therapies (time frame: through study completion, an average of 1 year). The study lists 4 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 NCT04344171, 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 21 Apr 2020.