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NCT04351529 Clinical Trial

Austrian COVID-19 Registry

COVID-19 Clinical Trial

Official title:
Austrian COVID-19 Registry (AGMT_COVID-19)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04351529
Other study ID # AGMT_COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date December 2021

Study information
Verified date November 2020
Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact Daniela Wolkersdorfer, Dr.
Phone +43 662 6404411
Email d.wolkersdorfer@agmt.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

Description:

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified at the end of 2019 in Wuhan, the capital of Hubei province in central China, and has since spread globally. There are currently no authorised vaccines or treatments in the EU (European Union) to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses. The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >=18 years - Positive test for SARS-CoV-2 Exclusion Criteria: - Due to the non-interventional design of the registry there are no specific exclusion criteria.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie) Feldkirch
Austria Kepler Universitätsklinikum Linz, Med. Campus III., Klinik für Lungenheilkunde / Pneumologie Linz
Austria IIIrd Medical Department, Private Medical University Hospital Salzburg Salzburg
Austria KH Zams: Innere Medizin Internistische Onkologie und Hämatologie Zams

Sponsors (1)
Lead Sponsor Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Documentation of natural course and the therapeutic landscape of patients with COVID-19. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician. 2 years
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