COVID-19 Registry Rhineland-Palatinate (Germany)

Sponsor
IHF GmbH - Institut für Herzinfarktforschung (Other)
Overall Status
Recruiting
CT.gov ID
NCT04335188
Collaborator
Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz (Other)
4,000
1
39.8
100.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prospective oberservational registry

Study Design

Study Type:
Observational
Anticipated Enrollment :
4000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
COVID-19 Registry Rhineland-Palatinate (Germany) - COVID-19 Disease Registry a National, Multicentre, Non-interventional, Prospective Observational Study
Actual Study Start Date :
Apr 6, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Chest x-ray [throughout study completion, in average 1.5 years]

    presence of infiltrates

  2. Chest CT [throughout study completion, in average 1.5 years]

    presence of infiltrates

  3. Supportive care - ICU [throughout study completion, in average 1.5 years]

    number of patients with ICU treatment required

  4. Supportive care - oxygen therapy [throughout study completion, in average 1.5 years]

    number of patients with oxygen therapy required

  5. Supportive care - ventilation [throughout study completion, in average 1.5 years]

    number of patients with ventilation required

  6. Medication [throughout study completion, in average 1.5 years]

    number of patients with medication changes

  7. Therapeutic strategies [throughout study completion, in average 1.5 years]

    number of patients with ECMO required

  8. Lab parameters [throughout study completion, in average 1.5 years]

    number of patients with significant changes in lab parameters

  9. Intra-hospital complications [throughout study completion, in average 1.5 years]

    number of patients with complications during hospital stay

  10. Vital status at discharge [throughout study completion, in average 1.5 years]

    vital status at discharge: alive, dead

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie Ludwigshafen RLP Germany 67063

Sponsors and Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT04335188
Other Study ID Numbers:
  • COVID-19 Registry
First Posted:
Apr 6, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022