NCT04952337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 7, 2021

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

October 27, 2020

Last Update Submit

July 2, 2021

Conditions

Keywords

COVID-19Community-Acquired PneumoniaCAPNETZ STIFTUNGCAPSARS-CoV-2

Outcome Measures

Primary Outcomes (3)

  • Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19

    Determination of specific molecular markers

    up to 1 year

  • Determination of the course of COVID-19

    Host factors (transcriptional response/RNA, proteins, antibodies) determine the course of COVID-19

    up to 1 year

  • Determination of the severity of COVID-19

    Host factors (transcriptional response/RNA, proteins, antibodies) determine the severity of COVID-19

    up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Krankenhaus Bad Arolsen

Bad Arolsen, Germany

NOT YET RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, Germany

NOT YET RECRUITING

HELIOS Klinikum Emil von Behring Berlin

Berlin, Germany

NOT YET RECRUITING

Vivantes Klinikum Neukölln

Berlin, Germany

NOT YET RECRUITING

Krankenhaus der Augustinerinnen

Cologne, Germany

NOT YET RECRUITING

Carl-Thiem-Klinikum Cottbus

Cottbus, Germany

NOT YET RECRUITING

Klinikum Dortmund gGmbH

Dortmund, Germany

RECRUITING

Universitätsklinikum Dresden

Dresden, Germany

NOT YET RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, Germany

NOT YET RECRUITING

Klinik Schillerhöhe

Gerlingen, Germany

NOT YET RECRUITING

Hannover Medical School

Hanover, Germany

NOT YET RECRUITING

Universitätsklinikum Jena

Jena, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

NOT YET RECRUITING

Universitätsklinikum rechts der Isar

München, Germany

NOT YET RECRUITING

Agaplesion Diakonieklinikum Rotenburg

Rotenburg (Wümme), Germany

NOT YET RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and materials of the respiratory tracts (upper and lower respiratory tracts)

MeSH Terms

Conditions

COVID-19Pneumonia, ViralPneumoniaPneumonia, BacterialCommunity-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBacterial InfectionsBacterial Infections and MycosesCommunity-Acquired Infections

Study Officials

  • Grit Barten-Neiner

    CAPNETZ Stiftung

    STUDY DIRECTOR

Central Study Contacts

Grit Barten-Neiner

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

July 7, 2021

Study Start

October 1, 2020

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

July 7, 2021

Record last verified: 2020-10

Locations