Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ) (PROVID-CAPNETZ)

July 2, 2021 updated by: Hannover Medical School

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Grit Barten-Neiner
  • Phone Number: +49-(0)511-532-4434
  • Email: office@capnetz.de

Study Locations

  • Germany
      • Bad Arolsen, Germany
        • Not yet recruiting
        • Krankenhaus Bad Arolsen
      • Berlin, Germany
        • Not yet recruiting
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany
        • Not yet recruiting
        • Vivantes Klinikum Neukölln
      • Berlin, Germany
        • Not yet recruiting
        • HELIOS Klinikum Emil von Behring Berlin
      • Cottbus, Germany
        • Not yet recruiting
        • Carl-Thiem-Klinikum Cottbus
      • Dortmund, Germany
      • Dresden, Germany
        • Not yet recruiting
        • Universitätsklinikum Dresden
      • Frankfurt, Germany
        • Not yet recruiting
        • Universitatsklinikum Frankfurt
      • Gerlingen, Germany
        • Not yet recruiting
        • Klinik Schillerhohe
      • Hannover, Germany
        • Not yet recruiting
        • Hannover Medical School
      • Jena, Germany
        • Not yet recruiting
        • Universitätsklinikum Jena
      • Köln, Germany
        • Not yet recruiting
        • Krankenhaus der Augustinerinnen
      • Lübeck, Germany
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • München, Germany
        • Not yet recruiting
        • Universitätsklinikum rechts der Isar
      • Rotenburg, Germany
        • Not yet recruiting
        • Agaplesion Diakonieklinikum Rotenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with positive detection of the SARS-CoV-2 virus (Coronavirus disease-19 (COVID-19))

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year
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
up to 1 year
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
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Charite University, Berlin, Germany
University of Leipzig

Investigators

  • Study Director: Grit Barten-Neiner, CAPNETZ Stiftung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROVID-CAPNETZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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