Clinical trial NCT04344171: CovidDB: The Covid-19 Inpatient Database
Official title: CovidDB: The Covid-19 Inpatient Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Sars-Cov-2
Covid-19
antiviral therapy
ventilation
ECMO
Lead sponsor: ClarData
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is focused on all Covid-19 inpatients which are treated in the recruited hospitals.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Covid-19 inpatients

Exclusion Criteria:

* assumed Covid-19 patient

Primary outcomes:
measure: Outcome comparison between different antiviral therapies
timeFrame: through study completion, an average of 1 year
measure: Outcome comparisons between ventilation types
timeFrame: through study completion, an average of 1 year
measure: Identification of risk factors
timeFrame: through study completion, an average of 1 year
measure: Number of days in hospital vs. clinical classification
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: RoMed - Klinikum Bad Aibling
city: Deggendorf
country: Germany
facility: DONAUISAR Klinikum Deggendorf
city: Dingolfing
country: Germany
facility: DONAUISAR Klinikum Dingolfing
city: Prien
country: Germany
facility: RoMed - Klinikum Prien am Chiemsee
city: Rosenheim
country: Germany
facility: RoMed - Klinikum Rosenheim
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wasserburg Am Inn
country: Germany
facility: RoMed - Klinikum Wasserburg Am Inn
city: Weißenburg
country: Germany
facility: Klinikum Altmühlfranken
city: Timisoara
country: Romania
facility: Timiş County Emergency Clinical Hospital
Study officials:
affiliation: ClarData
name: Julia Ferencz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Giessen
name: Hans-Rudolf Tinneberg, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.