COVID-19 Registry Rhineland-Palatinate (Germany)

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335188
• Other study ID #: COVID-19 Registry
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2589
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

Other:
• Prospective oberservational registry
Non interventional study.

Locations

Country	Name	City	State
Germany	Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie	Ludwigshafen	RLP

Sponsors (2)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz

Country where clinical trial is conducted

Germany, 

Outcome

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