COVID-19 Registry Rhineland-Palatinate (Germany)

NCT04335188 | Completed

• 1 other identifier: COVID-19 Registry
• Study Type: observational
• Target: 2,589
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

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

Interventions

Prospective oberservational registry OTHER

Non interventional study.

In-patients with SARS-CoV-2 infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• In-patients fulfilling the following criteria:
• SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead
• Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz: collaborator

Study Sites (1)

Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie

Ludwigshafen, RLP, 67063, Germany

Location

Study Officials

• Anselm Gitt, MD

  Stiftung IHF and Klinikum der Stadt Ludwigshafen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: April 6, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

DE (1)