Clinical trial NCT04952337: Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)
Official title: Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Viral Pneumonia
Pneumonia Due to Streptococcus Pneumoniae
Bacterial Pneumonia
Pneumonia Due to H. Influenzae
Pneumonia, Organism Unspecified
Pneumonia in Diseases Classified Elsewhere
Pneumonia Due to Other Specified Infectious Organisms
Keywords: COVID-19
Community-Acquired Pneumonia
CAPNETZ STIFTUNG
CAP
SARS-CoV-2
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University of Leipzig
First posted: 2021-07-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with positive detection of the SARS-CoV-2 virus (Coronavirus disease-19 (COVID-19))

Brief 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.

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.

1. 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,

1. host factors (transcriptional response/RNA, proteins, antibodies) determine the severity and/or course of COVID-19,
2. 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,
3. specific molecular markers of severe disease can be tested as therapeutic targets for COVID-19.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19
timeFrame: up to 1 year
measure: Determination of the course of COVID-19
timeFrame: up to 1 year
measure: Determination of the severity of COVID-19
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Arolsen
country: Germany
facility: Krankenhaus Bad Arolsen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gerlingen
country: Germany
facility: Klinik Schillerhöhe
city: Hannover
country: Germany
facility: Hannover Medical School
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Köln
country: Germany
facility: Krankenhaus der Augustinerinnen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: München
country: Germany
facility: Universitätsklinikum rechts der Isar
city: Rotenburg
country: Germany
facility: Agaplesion Diakonieklinikum Rotenburg
Study officials:
affiliation: CAPNETZ Stiftung
name: Grit Barten-Neiner
role: STUDY_DIRECTOR
References: