Austrian COVID-19 Registry

Austrian COVID-19 Registry (AGMT_COVID-19)

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Infectious Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • Recruiting
    • LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)
    • Principal Investigator: Thomas Winder, MD
  • Linz, Austria, 4021
    • Recruiting
    • Kepler Universitätsklinikum Linz, Med. Campus III., Klinik für Lungenheilkunde / Pneumologie
  • Salzburg, Austria, 5020
    • Recruiting
    • IIIrd Medical Department, Private Medical University Hospital Salzburg
    • Contact: Richard Greil, MD
  • Zams, Austria, 6511
    • Recruiting
    • KH Zams: Innere Medizin Internistische Onkologie und Hämatologie
    • Principal Investigator: Ewald Wöll, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Investigators: Principal Investigator: Richard Greil, MD, IIIrd Medical Department, Private Medical University Hospital Salzburg

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: AGMT_COVID-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No