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Austrian COVID-19 Registry

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ClinicalTrials.gov Identifier: NCT04351529
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief 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.


Condition or disease
Infectious Disease COVID-19

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Austrian COVID-19 Registry (AGMT_COVID-19)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351529


Contacts
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Contact: Daniela Wolkersdorfer, Dr. +43 662 6404411 d.wolkersdorfer@agmt.at
Contact: Stephanie Esmaeilzadeh-Leithner, MSc. +43 662 6404413 s.leithner@agmt.at

Locations
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Austria
IIIrd Medical Department, Private Medical University Hospital Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, MD         
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
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Principal Investigator: Richard Greil, MD IIIrd Medical Department, Private Medical University Hospital Salzburg
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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT04351529    
Other Study ID Numbers: AGMT_COVID-19
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection