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Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19

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ClinicalTrials.gov Identifier: NCT04977934
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
University of Jena
Information provided by (Responsible Party):
Prof. Dr. med. Martin Witzenrath, Charite University, Berlin, Germany

Brief Summary:

The aim of the joint project PROVID is to contribute to better outcome prediction for COVID-19 patients, to better clinical management, and to the development of new therapies. To this end, the investigators will collect detailed data on the course of COVID-19 patients and deeply characterize them at the molecular level. The investigators also aim to identify compounds with the potential to improve outcome.

The PROVID-PROGRESS study is being carried out as a prospective, longitudinal, multicenter observational study (case cohort study) with material asservation for genomic, transcriptomic and proteomic analyzes on adult patients with COVID-19.


Condition or disease
COVID-19 Pneumonia

Detailed Description:

With COVID-19, severe lung damage can be associated with relative well-being. In the course of disease (several days), sudden lung failure may occur. While the lung initially shows a relatively high compliance after intubation, lung function deteriorates rapidly to severe ARDS in most patients. After intubation, patients require mechanical ventilation over a relatively long period of time (17 days on average).

To improve the clinical management of COVID-19 and its complications, there is an urgent need for clinical (e.g., scores) and molecular (e.g., biomarkers) predictors of COVID-19 progression and for new therapeutic targets. Advanced age and comorbidities have been identified as risk factors for fatal disease progression.

After study inclusion, comprehensive baseline documentation of anamnestic, clinical and laboratory data is collected on the same day if possible. In addition, all parameters are collected that may be necessary to assess the severity of a COVID-19 disease (e.g. SOFA, PSI, C (U) RB-65, ATS minor criteria). Furthermore, data is collected which, according to the current state of knowledge, may be suitable for an assessment of the prognosis of the COVID-19 disease. In particular, questions are asked about known infection risks (living environment of the patient, lifestyle, previous illnesses, immune competence), the history of symptoms and tests relating to COVID-19, preexisting medication, the familial risk of infection as well as ethnicity.

On the day of inclusion (day 0) and on study visit days 1-6 and 13 - or for discharge if this occurs before day 6 or day 13 after inclusion - routine laboratory values, score-relevant data, concomitant medication and microbiological findings are documented.

On discharge of the patient, additional information about his whereabouts is collected. If the patient dies, the date and cause of death are documented.

On days 28, 180 and 360 after inclusion in the study, a follow-up survey takes place with particular attention to the living conditions and quality of life of the patient (EuroQol health questionnaire EQ-5D-3L), to health-related events such as stroke or heart attack and to the vital status. If the patient cannot be reached for the follow-up questionnaires, the including study center will attempt to determine the current contact details or vital status from relatives, the family doctor or, if necessary, from data from the residents' registration offices or other state registers, provided that consent is given.

On study visit days 0, 1-3, 6 and 13, 4 blood samples each (P100 EDTA plasma, citrate plasma, serum and PAXgene RNA) are taken. A DNA sample (EDTA whole blood) is taken once and at any time.

A nasopharynx swab is obtained on days 0, 3 and 6. If possible, sputum is obtained for inclusion and on visit day 6.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROVID-PROGRESS - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Severity of disease (number and rate of patients treated on intensive care unit or dead) [ Time Frame: Between enrollment and day thirteen ]

Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days ]
  2. length of ICU treatment [ Time Frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days ]
  3. length of mechanical ventilation [ Time Frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days ]
  4. Number and rate of patients with organ involvement (complications) [ Time Frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days ]
  5. Number and rate of patients with COVID-19-related long-term effects assessed by EQ-5D-3L questionnaire [ Time Frame: From date of hospitalization until day 365 after recruitment ]
  6. Number and rate of patients with changes in quality of life, assessed by EQ-5D-3L questionnaire [ Time Frame: From date one month before study enrolement in hospital until day 365 after recruitment ]

Biospecimen Retention:   Samples With DNA
DNA from EDTA whole blood, RNA from stabilized whole blood, serum, citrate plasma, stabilized EDTA plasma, urin, oropharynx swab, nasopharynx swab, sputum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult hospitalized patients tested positive for SARS-CoV-2. Patients can be enrolled in general care, intensive care, and in emergency departments.
Criteria

Inclusion Criteria:

  • Positive detection of SARS-CoV-2-virus
  • Informed consent signed

Exclusion Criteria:

  • Patient participation in PROVID-CAPNETZ, PROVID-PROGRESS or PROVID- CAPSyS at an earlier time
  • simultaneous participation in PROVID-CAPNETZ
  • pregnancy
  • breast feeding period
  • active tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977934


Contacts
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Contact: Agata Mikolajewska, MD +49-30-450653559 agata.mikolajewska@charite.de
Contact: Peter Ahnert, PhD +49-341-9716282 peter.ahnert@imise.uni-leipzig.de

Locations
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Austria
Kepler Universitätsklinikukm GmbH, Med Campus III Recruiting
Linz, Austria
Germany
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie Recruiting
Berlin, Germany
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III Not yet recruiting
Halle (Saale), Germany
Klinik St. Georg gGmbH; Klinik für Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie Recruiting
Leipzig, Germany
Universitätsklinikum Leipzig, Medizinische Klinik II - Bereich Pneumologie Recruiting
Leipzig, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
University of Leipzig
University of Jena
Investigators
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Principal Investigator: Martin Witzenrath, MD Charite University
Additional Information:
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Responsible Party: Prof. Dr. med. Martin Witzenrath, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04977934    
Other Study ID Numbers: PROVID-PROGRESS
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual-level participant data along with the study protocol will be made available for qualified research on respiratory tract infections and immunology as defined by informed consent given by patients. Researchers may send a short research proposal for approval by the PROVID Board via progress-study-group@imise.uni-leipzig.de. A data access and use agreement needs to be signed. Provided data may be used only for approved purposes and for the duration agreed upon in the data access and use agreement. Data use applications will be accepted by the PROVID board after the study has finished and data quality has been assured.
Supporting Materials: Study Protocol
Time Frame:

Data use applications will be accepted by the PROVID board after the study has finished and data quality has been assured.

Data will be provided for the duration specified in the data access and use agreement.

Access Criteria: Study data can be accessed for qualified research on respiratory tract infections and immunology as defined by informed consent given by patients and evaluated by the PROVID board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Martin Witzenrath, Charite University, Berlin, Germany:
COVID-19
SARS-CoV-2
Pneumonia
PROGRESS
PROVID
Coronavirus
Sepsis
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases