Austrian COVID-19 Registry

November 26, 2020 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Investigators

  • Principal Investigator: Richard Greil, MD, IIIrd Medical Department, Private Medical University Hospital Salzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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