COVID-19PROVID-CAPNETZNCT04952337
Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)
An observational study of COVID-19 and Viral Pneumonia, run by Hannover Medical School at 15 sites in Germany.
Trial summary
The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Viral Pneumonia, Pneumonia Due to Streptococcus Pneumoniae
- How many people
- 400 participants
- Where
- 15 sitesGermany
- Study dates
- 1 Oct 2020to 1 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with positive detection of the SARS-CoV-2 virus (Coronavirus disease-19 (COVID-19))
Who may be able to join
- Age ≥ 18
- Radiological proof of infiltrate (primarily chest x-ray or CT) with positive detection of SARS-CoV-2-virus or with no proven infiltrate with positive detection of SARS-CoV-2-virus
- Informed consent signed
Who cannot join
- Newly diagnosed, active pulmonary tuberculosis within the last 2 months
- Simultaneous participation in PROVID-PROGRESS or PROVID-CAPSyS cohort
- Participation of the patient in PROVID-PROGRESS or PROVID-CAPSyS cohort at an earlier point in time
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites, 15 recruiting
- Not yet recruiting
Krankenhaus Bad Arolsen
Bad Arolsen
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin
- Not yet recruiting
HELIOS Klinikum Emil von Behring Berlin
Berlin
- Not yet recruiting
Vivantes Klinikum Neukölln
Berlin
- Not yet recruiting
Krankenhaus der Augustinerinnen
Cologne
- Not yet recruiting
Carl-Thiem-Klinikum Cottbus
Cottbus
- Recruiting
Klinikum Dortmund gGmbH
Dortmund
Bernhard Schaaf, PD Dr., +49 (0)231 953-18100, bernhard.schaaf@klinikumdo.de
- Not yet recruiting
Universitätsklinikum Dresden
Dresden
- Not yet recruiting
Universitätsklinikum Frankfurt
Frankfurt
- Not yet recruiting
Klinik Schillerhöhe
Gerlingen
- Not yet recruiting
Hannover Medical School
Hanover
- Not yet recruiting
Universitätsklinikum Jena
Jena
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck
- Not yet recruiting
Universitätsklinikum rechts der Isar
München
- Not yet recruiting
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme)
About this study
The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19.
The aim of the joint project PROVID is to draw conclusions from the often very different clinical appearance of infections with the SARS-CoV-2 pathogen in order to improve patient care through targeted clinical management.
Read more
The effects of infections with the SARS-CoV-2 pathogen are wide-ranging and include a spectrum from symptomlessness to infections of the upper respiratory tract, uncomplicated but also severe pneumonia with lung failure and high mortality.
PROVID will first check whether certain host factors determine the severity and / or the course of Covid-19. Research is also being carried out into whether the molecular and clinical values of Covid-19 patients differ from those of patients with pneumonia caused by other pathogens. In addition, it will be tested whether specific molecular markers describe the severity of the disease and are suitable as an aid for targeted therapy for Covid-19.
PROVID is an interdisciplinary joint project made up of three sub-projects that are being implemented at three locations (Charitè-Universitätsmedizin Berlin, Universität Leipzig IMISE and CAPNETZ STIFTUNG / Hannover).
PROVID is based on three clinical research platforms with a high track record in recruiting patients with high-quality data and biomaterials on the one hand and guideline-changing results on the other hand: CAPNETZ (competence network CAP, since 2002, world's largest database and biobank for CAP), PROGRESS (Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis, since 2007) and CAPSyS (systems medicine of community-acquired pneumonia, since 2014).
The COVID-19 patients are recruited into 3 different patient cohorts via these 3 research platforms.
- PROVID-CAPNETZ, 2. PROVID-PROGRESS, 3. PROVID-CAPSyS.
Read the detailed description
Infections with the novel Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) manifest with a broad spectrum of clinical presentations, ranging from asymptomatic to upper respiratory tract infections, uncomplicated pneumonia and severe pneumonia with respiratory failure and high lethality. Despite more than 1.7 Mio. documented infections worldwide, a profound lack of knowledge impedes clinical management and the development of therapies. COVID-19-associated pneumonia and lung injury differ in relevant details from any of the known types of pneumonia that cause respiratory failure, including viral infections like influenza or MERS-CoV. Thus, it is unclear whether specific decision guidelines established for pneumonia are applicable or whether these need to be refined for COVID-19. That is why the PROVID consortium was founded with BMBF funding. The PROVID consortium thus aims to characterize the host- and virusdependent mechanisms associated with the clinical appearance of COVID-19 to improve patient care through advances in risk stratification and clinical management. Specifically, we aim to test the hypotheses that,
- host factors (transcriptional response/RNA, proteins, antibodies) determine the severity and/or course of COVID-19,
- molecular and clinical determinants of COVID-19 differ from those previously deciphered in other types of pneumonia and they can be used as molecular predictors for disease progression,
- specific molecular markers of severe disease can be tested as therapeutic targets for COVID-19.
- In addition to presently pursued antivirals and immunomodulators, the stabilization of the pulmonary barrier function could establish a third line for an effective therapy.
In PROVID we synergistically combine our expertise in the areas of pneumonia and ARDS, infection immunology, molecular and medical virology, lung physiology and endothelial cell biology, experimental lung infection research, statistics and bioinformatics.
- Conditions
- COVID-19, Viral Pneumonia, Pneumonia Due to Streptococcus Pneumoniae, Bacterial Pneumonia, Pneumonia Due to H. Influenzae, Pneumonia, Organism Unspecified
- Keywords
- COVID-19, Community-Acquired Pneumonia, CAPNETZ STIFTUNG, CAP, SARS-CoV-2
- Medical subject headings
- COVID-19, Pneumonia, Viral, Pneumonia, Pneumonia, Bacterial, Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19
Determination of specific molecular markers
Measured: up to 1 year
Determination of the course of COVID-19
Host factors (transcriptional response/RNA, proteins, antibodies) determine the course of COVID-19
Measured: up to 1 year
Determination of the severity of COVID-19
Host factors (transcriptional response/RNA, proteins, antibodies) determine the severity of COVID-19
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Oct 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Leipzig
- Responsible party
- Sponsor
- Investigators
- Grit Barten-Neiner, Study director, Capnetz Stiftung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952337
- Sponsor's protocol ID
- PROVID-CAPNETZ
- Acronym
- PROVID-CAPNETZ
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 7 Jul 2021
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)
- ClinicalTrials.gov ID
- NCT04952337
- Acronym / sponsor ID
- PROVID-CAPNETZ / PROVID-CAPNETZ
- Conditions
- COVID-19, Viral Pneumonia, Pneumonia Due to Streptococcus Pneumoniae, Bacterial Pneumonia, Pneumonia Due to H. Influenzae, Pneumonia, Organism Unspecified
- Keywords
- COVID-19, Community-Acquired Pneumonia, CAPNETZ STIFTUNG, CAP, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Leipzig
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Jul 2021 (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.
The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19.
The aim of the joint project PROVID is to draw conclusions from the often very different clinical appearance of infections with the SARS-CoV-2 pathogen in order to improve patient care through targeted clinical management.
The effects of infections with the SARS-CoV-2 pathogen are wide-ranging and include a spectrum from symptomlessness to infections of the upper respiratory tract, uncomplicated but also severe pneumonia with lung failure and high mortality.
PROVID will first check whether certain host factors determine the severity and / or the course of Covid-19. Research is also being carried out into whether the molecular and clinical values of Covid-19 patients differ from those of patients with pneumonia caused by other pathogens. In addition, it will be tested whether specific molecular markers describe the severity of the disease and are suitable as an aid for targeted therapy for Covid-19.
PROVID is an interdisciplinary joint project made up of three sub-projects that are being implemented at three locations (Charitè-Universitätsmedizin Berlin, Universität Leipzig IMISE and CAPNETZ STIFTUNG / Hannover).
PROVID is based on three clinical research platforms with a high track record in recruiting patients with high-quality data and biomaterials on the one hand and guideline-changing results on the other hand: CAPNETZ (competence network CAP, since 2002, world's largest database and biobank for CAP), PROGRESS (Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis, since 2007) and CAPSyS (systems medicine of community-acquired pneumonia, since 2014).
The COVID-19 patients are recruited into 3 different patient cohorts via these 3 research platforms.
- PROVID-CAPNETZ, 2. PROVID-PROGRESS, 3. PROVID-CAPSyS.
Detailed description
Infections with the novel Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) manifest with a broad spectrum of clinical presentations, ranging from asymptomatic to upper respiratory tract infections, uncomplicated pneumonia and severe pneumonia with respiratory failure and high lethality. Despite more than 1.7 Mio. documented infections worldwide, a profound lack of knowledge impedes clinical management and the development of therapies. COVID-19-associated pneumonia and lung injury differ in relevant details from any of the known types of pneumonia that cause respiratory failure, including viral infections like influenza or MERS-CoV. Thus, it is unclear whether specific decision guidelines established for pneumonia are applicable or whether these need to be refined for COVID-19. That is why the PROVID consortium was founded with BMBF funding. The PROVID consortium thus aims to characterize the host- and virusdependent mechanisms associated with the clinical appearance of COVID-19 to improve patient care through advances in risk stratification and clinical management. Specifically, we aim to test the hypotheses that,
- host factors (transcriptional response/RNA, proteins, antibodies) determine the severity and/or course of COVID-19,
- molecular and clinical determinants of COVID-19 differ from those previously deciphered in other types of pneumonia and they can be used as molecular predictors for disease progression,
- specific molecular markers of severe disease can be tested as therapeutic targets for COVID-19.
- In addition to presently pursued antivirals and immunomodulators, the stabilization of the pulmonary barrier function could establish a third line for an effective therapy.
In PROVID we synergistically combine our expertise in the areas of pneumonia and ARDS, infection immunology, molecular and medical virology, lung physiology and endothelial cell biology, experimental lung infection research, statistics and bioinformatics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with positive detection of the SARS-CoV-2 virus (Coronavirus disease-19 (COVID-19))
Key inclusion criteria (3 listed)
- Age ≥ 18
- Radiological proof of infiltrate (primarily chest x-ray or CT) with positive detection of SARS-CoV-2-virus or with no proven infiltrate with positive detection of SARS-CoV-2-virus
- Informed consent signed
Key exclusion criteria (3 listed)
- Newly diagnosed, active pulmonary tuberculosis within the last 2 months
- Simultaneous participation in PROVID-PROGRESS or PROVID-CAPSyS cohort
- Participation of the patient in PROVID-PROGRESS or PROVID-CAPSyS cohort at an earlier point in time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19
Time frame: up to 1 year
Determination of specific molecular markers
Determination of the course of COVID-19
Time frame: up to 1 year
Host factors (transcriptional response/RNA, proteins, antibodies) determine the course of COVID-19
Determination of the severity of COVID-19
Time frame: up to 1 year
Host factors (transcriptional response/RNA, proteins, antibodies) determine the severity of COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Related InfoLink provided by the sponsor.
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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.
Grit Barten-Neiner study director
Capnetz Stiftung
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Viral Pneumonia, run by Hannover Medical School at 15 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grit Barten-Neiner (+49-(0)511-532-4434, office@capnetz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19 (time frame: up to 1 year). The study lists 3 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 7 Jul 2021.