COVIDNCT04335188
COVID-19 Registry Rhineland-Palatinate (Germany)
An observational study of COVID, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- What is being tested?
- Prospective oberservational registry
- How many people
- 2,589 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- In-patients fulfilling the following criteria:
- SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study
Who cannot join
- No explicit medical exclusion criteria are stated to avoid selection bias.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie
Ludwigshafen, RLP, 67063
About this study
Official title: 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.
- Conditions
- COVID
- Being tested
- Prospective oberservational registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective oberservational registryOther
Non interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prospective oberservational registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest x-ray
presence of infiltrates
Measured: throughout study completion, in average 1.5 years
Chest CT
presence of infiltrates
Measured: throughout study completion, in average 1.5 years
Supportive care - ICU
number of patients with ICU treatment required
Measured: throughout study completion, in average 1.5 years
Supportive care - oxygen therapy
number of patients with oxygen therapy required
Measured: throughout study completion, in average 1.5 years
Supportive care - ventilation
number of patients with ventilation required
Measured: throughout study completion, in average 1.5 years
Medication
number of patients with medication changes
Measured: throughout study completion, in average 1.5 years
Therapeutic strategies
number of patients with ECMO required
Measured: throughout study completion, in average 1.5 years
Lab parameters
number of patients with significant changes in lab parameters
Measured: throughout study completion, in average 1.5 years
Intra-hospital complications
number of patients with complications during hospital stay
Measured: throughout study completion, in average 1.5 years
Vital status at discharge
vital status at discharge: alive, dead
Measured: throughout study completion, in average 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start6 Apr 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,589 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz
- Responsible party
- Sponsor
- Investigators
- Anselm Gitt, MD, Study chair, Stiftung IHF and Klinikum der Stadt Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335188
- Sponsor's protocol ID
- COVID-19 Registry
- Status last verified
- May 2023
- First submitted
- 31 Mar 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Registry Rhineland-Palatinate (Germany) - COVID-19 Disease Registry a National, Multicentre, Non-interventional, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04335188
- Acronym / sponsor ID
- COVID-19 Registry
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,589 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-patients with SARS-CoV-2 infection | – | Other: Prospective oberservational registryIn-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- In-patients fulfilling the following criteria:
- SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study
Key exclusion criteria (1 listed)
- No explicit medical exclusion criteria are stated to avoid selection bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective oberservational registryNon interventional study. | Other | In-patients with SARS-CoV-2 infection |
Primary outcome
Chest x-ray
Time frame: throughout study completion, in average 1.5 years
presence of infiltrates
Chest CT
Time frame: throughout study completion, in average 1.5 years
presence of infiltrates
Supportive care - ICU
Time frame: throughout study completion, in average 1.5 years
number of patients with ICU treatment required
Supportive care - oxygen therapy
Time frame: throughout study completion, in average 1.5 years
number of patients with oxygen therapy required
Supportive care - ventilation
Time frame: throughout study completion, in average 1.5 years
number of patients with ventilation required
Medication
Time frame: throughout study completion, in average 1.5 years
number of patients with medication changes
Therapeutic strategies
Time frame: throughout study completion, in average 1.5 years
number of patients with ECMO required
Lab parameters
Time frame: throughout study completion, in average 1.5 years
number of patients with significant changes in lab parameters
Intra-hospital complications
Time frame: throughout study completion, in average 1.5 years
number of patients with complications during hospital stay
Vital status at discharge
Time frame: throughout study completion, in average 1.5 years
vital status at discharge: alive, dead
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anselm Gitt, MD study chair
Stiftung IHF and Klinikum der Stadt Ludwigshafen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest x-ray (time frame: throughout study completion, in average 1.5 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.