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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04344171
Other study ID # CovidDB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2020
Est. completion date June 30, 2023

Study information

Verified date April 2020
Source ClarData
Contact Julia Ferencz, MD
Phone +4917687607223
Email j.ferencz@clardata.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Covid-19 inpatients

Exclusion Criteria:

- assumed Covid-19 patient

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany RoMed - Klinikum Bad Aibling Bad Aibling
Germany DONAUISAR Klinikum Deggendorf Deggendorf
Germany DONAUISAR Klinikum Dingolfing Dingolfing
Germany RoMed - Klinikum Prien am Chiemsee Prien
Germany RoMed - Klinikum Rosenheim Rosenheim
Germany Universitätsklinikum Ulm Ulm
Germany RoMed - Klinikum Wasserburg Am Inn Wasserburg Am Inn
Germany Klinikum Altmühlfranken Weißenburg
Romania Timis County Emergency Clinical Hospital Timisoara

Sponsors (1)

Lead Sponsor Collaborator
ClarData

Countries where clinical trial is conducted

Germany,  Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome comparison between different antiviral therapies Different antivirals and their combinations will be tested and the outcome (cured/deceased) will be assessed through study completion, an average of 1 year
Primary Outcome comparisons between ventilation types Different ventilation types will be tested and the outcome (cured/deceased) will be assessed through study completion, an average of 1 year
Primary Identification of risk factors Clinical and laboratory risk factors will be recorded and the outcome (cured/deceased) will be assessed through study completion, an average of 1 year
Primary Number of days in hospital vs. clinical classification Correlation between number of days in hospital and worst clinical classification will be calculated through study completion, an average of 1 year
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