COVID-19 PneumoniaNCT04977934
Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
An observational study of COVID-19 Pneumonia, run by Charite University, Berlin, Germany at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- How many people
- 94 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Jan 2021to 30 Jun 2023
- 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
- Adult, Older adult
Study population: Adult hospitalized patients tested positive for SARS-CoV-2. Patients can be enrolled in general care, intensive care, and in emergency departments.
Who may be able to join
- Positive detection of SARS-CoV-2-virus
- Informed consent signed
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie
Berlin
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III
Halle
Klinik St. Georg gGmbH; Klinik für Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
Leipzig
Universitätsklinikum Leipzig, Medizinische Klinik II - Bereich Pneumologie
Leipzig
About this study
Official title: PROVID-PROGRESS - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, SARS-CoV-2, Pneumonia, PROGRESS, PROVID, Coronavirus, Sepsis
- Medical subject headings
- COVID-19, Pneumonia, Coronavirus Infections, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of disease (number and rate of patients treated on intensive care unit or dead)
Measured: Between enrollment and day thirteen
Secondary outcomes (6)
Length of hospitalization
Measured: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
length of ICU treatment
Measured: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
length of mechanical ventilation
Measured: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
Number and rate of patients with organ involvement (complications)
Measured: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
Number and rate of patients with COVID-19-related long-term effects assessed by EQ-5D-3L questionnaire
Measured: From date of hospitalization until day 365 after recruitment
Number and rate of patients with changes in quality of life, assessed by EQ-5D-3L questionnaire
Measured: From date one month before study enrolement in hospital until day 365 after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start20 Jan 2021
- Primary completion31 May 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, University of Leipzig, University of Jena
- Responsible party
- Principal investigator, Prof. Dr. med. Martin Witzenrath, Charite University, Berlin, Germany
- Investigators
- Martin Witzenrath, MD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977934
- Sponsor's protocol ID
- PROVID-PROGRESS
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVID-PROGRESS - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
- ClinicalTrials.gov ID
- NCT04977934
- Acronym / sponsor ID
- PROVID-PROGRESS
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, SARS-CoV-2, Pneumonia, PROGRESS, PROVID, Coronavirus, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, University of Leipzig, University of Jena
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized patients tested positive for SARS-CoV-2. Patients can be enrolled in general care, intensive care, and in emergency departments.
Key inclusion criteria (2 listed)
- Positive detection of SARS-CoV-2-virus
- Informed consent signed
Key exclusion criteria (5 listed)
- 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
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
Severity of disease (number and rate of patients treated on intensive care unit or dead)
Time frame: Between enrollment and day thirteen
6 secondary outcomes
Length of hospitalization
Time frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
length of ICU treatment
Time frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
length of mechanical ventilation
Time frame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Study website in the portal of the Federal Ministry of Education and ResearchLink provided by the sponsor.
- Study portal for access to electronic case report form (eCRF)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Martin Witzenrath, MD principal investigator
Charite University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Charite University, Berlin, Germany at 5 sites in 2 countries.
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 2 inclusion and 5 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of disease (number and rate of patients treated on intensive care unit or dead) (time frame: Between enrollment and day thirteen). 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 20 Jul 2022.