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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infection
• Infectious Disease

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