CovidDB: The Covid-19 Inpatient Database
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| ClinicalTrials.gov Identifier: NCT04344171 |
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Recruitment Status :
Recruiting
First Posted : April 14, 2020
Last Update Posted : April 21, 2020
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| Condition or disease |
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| COVID-19 |
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 Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | CovidDB: The Covid-19 Inpatient Database |
| Actual Study Start Date : | March 30, 2020 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | June 30, 2023 |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Covid-19 inpatients
Exclusion Criteria:
- assumed Covid-19 patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344171
| Contact: Julia Ferencz, MD | +4917687607223 | j.ferencz@clardata.com | |
| Contact: Sebastian Dieng | +4915140212025 | s.dieng@clardata.com |
| Germany | |
| RoMed - Klinikum Bad Aibling | Recruiting |
| Bad Aibling, Germany | |
| Contact: Stefan Budweiser, Prof. | |
| DONAUISAR Klinikum Deggendorf | Not yet recruiting |
| Deggendorf, Germany | |
| Contact: Adi Kovacevic, Dr. | |
| DONAUISAR Klinikum Dingolfing | Not yet recruiting |
| Dingolfing, Germany | |
| Contact: Heribert Fröschl, Dr. | |
| RoMed - Klinikum Prien am Chiemsee | Recruiting |
| Prien, Germany | |
| Contact: Stefan Budweiser, Prof. | |
| RoMed - Klinikum Rosenheim | Recruiting |
| Rosenheim, Germany | |
| Contact: Stefan Budweiser, Prof. | |
| Universitätsklinikum Ulm | Recruiting |
| Ulm, Germany | |
| Contact: Thomas Seufferlein, Prof | |
| RoMed - Klinikum Wasserburg Am Inn | Recruiting |
| Wasserburg Am Inn, Germany | |
| Contact: Stefan Budweiser, Prof. | |
| Klinikum Altmühlfranken | Recruiting |
| Weißenburg, Germany | |
| Contact: Marius Ghidau, Dr. | |
| Romania | |
| Timiş County Emergency Clinical Hospital | Recruiting |
| Timisoara, Romania | |
| Contact: Ovidiu Bedreag, Prof. | |
| Principal Investigator: | Julia Ferencz, MD | ClarData | |
| Principal Investigator: | Hans-Rudolf Tinneberg, Prof. | University of Giessen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ClarData |
| ClinicalTrials.gov Identifier: | NCT04344171 |
| Other Study ID Numbers: |
CovidDB |
| First Posted: | April 14, 2020 Key Record Dates |
| Last Update Posted: | April 21, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Sars-Cov-2 Covid-19 antiviral therapy ventilation ECMO |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |