COVID-19 Registry Rhineland-Palatinate (Germany)

May 4, 2023 updated by: IHF GmbH - Institut für Herzinfarktforschung

COVID-19 Registry Rhineland-Palatinate (Germany) - COVID-19 Disease Registry a National, Multicentre, Non-interventional, Prospective Observational Study

Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2589

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anselm Gitt, MD
  • Phone Number: +49 621 5032944
  • Email: gitta@klilu.de

Study Contact Backup

  • Name: Sebastian Diebold, PhD
  • Phone Number: +4962159577214
  • Email: diebold@ihf.de

Study Locations

  • Germany
    • RLP
      • Ludwigshafen, RLP, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

About 110 hospitals in Rhineland-Palatinate (Germany) treating patients with SARS-CoV-2 infection.

All stationary treated patients with SARS-CoV-2 infection will be included.

Preferably all hospitals in Rhineland-Palatinate, Germany, treating patients with SARS-CoV-2 infection.

Consecutive enrolment of all patients fulfilling the patient selection criteria to avoid selection bias.

Description

Inclusion Criteria:

  • In-patients fulfilling the following criteria:

SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study

Exclusion Criteria:

  • No explicit medical exclusion criteria are stated to avoid selection bias.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
In-patients with SARS-CoV-2 infection

In-patients fulfilling the following criteria:

SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study No explicit medical exclusion criteria are stated to avoid selection bias.
Other: Prospective oberservational registry
Non interventional study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chest x-ray
Time Frame: throughout study completion, in average 1.5 years
presence of infiltrates
throughout study completion, in average 1.5 years
Chest CT
Time Frame: throughout study completion, in average 1.5 years
presence of infiltrates
throughout study completion, in average 1.5 years
Supportive care - ICU
Time Frame: throughout study completion, in average 1.5 years
number of patients with ICU treatment required
throughout study completion, in average 1.5 years
Supportive care - oxygen therapy
Time Frame: throughout study completion, in average 1.5 years
number of patients with oxygen therapy required
throughout study completion, in average 1.5 years
Supportive care - ventilation
Time Frame: throughout study completion, in average 1.5 years
number of patients with ventilation required
throughout study completion, in average 1.5 years
Medication
Time Frame: throughout study completion, in average 1.5 years
number of patients with medication changes
throughout study completion, in average 1.5 years
Therapeutic strategies
Time Frame: throughout study completion, in average 1.5 years
number of patients with ECMO required
throughout study completion, in average 1.5 years
Lab parameters
Time Frame: throughout study completion, in average 1.5 years
number of patients with significant changes in lab parameters
throughout study completion, in average 1.5 years
Intra-hospital complications
Time Frame: throughout study completion, in average 1.5 years
number of patients with complications during hospital stay
throughout study completion, in average 1.5 years
Vital status at discharge
Time Frame: throughout study completion, in average 1.5 years
vital status at discharge: alive, dead
throughout study completion, in average 1.5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHF GmbH - Institut für Herzinfarktforschung

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anselm Gitt, MD, Stiftung IHF and Klinikum der Stadt Ludwigshafen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-19 Registry

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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