COVID-19 Registry Rhineland-Palatinate (Germany)

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: Completed
• Conditions: COVID
• Intervention / Treatment: Other: Prospective oberservational registry

• Study Type: Observational
• Enrollment (Actual): 2589

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Chest x-ray	presence of infiltrates	throughout study completion, in average 1.5 years
Chest CT	presence of infiltrates	throughout study completion, in average 1.5 years
Supportive care - ICU	number of patients with ICU treatment required	throughout study completion, in average 1.5 years
Supportive care - oxygen therapy	number of patients with oxygen therapy required	throughout study completion, in average 1.5 years
Supportive care - ventilation	number of patients with ventilation required	throughout study completion, in average 1.5 years
Medication	number of patients with medication changes	throughout study completion, in average 1.5 years
Therapeutic strategies	number of patients with ECMO required	throughout study completion, in average 1.5 years
Lab parameters	number of patients with significant changes in lab parameters	throughout study completion, in average 1.5 years
Intra-hospital complications	number of patients with complications during hospital stay	throughout study completion, in average 1.5 years
Vital status at discharge	vital status at discharge: alive, dead	throughout study completion, in average 1.5 years

Collaborators and Investigators

• Sponsor: IHF GmbH - Institut für Herzinfarktforschung
• Collaborators: Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz
• Investigators: Study Chair: Anselm Gitt, MD, Stiftung IHF and Klinikum der Stadt Ludwigshafen

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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