Clinical trial NCT04977934: Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
Official title: PROVID-PROGRESS - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
SARS-CoV-2
Pneumonia
PROGRESS
PROVID
Coronavirus
Sepsis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: University of Leipzig
name: University of Jena
First posted: 2021-07-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Severity of disease (number and rate of patients treated on intensive care unit or dead)
timeFrame: Between enrollment and day thirteen
Secondary outcomes:
measure: Length of hospitalization
timeFrame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
measure: length of ICU treatment
timeFrame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
measure: length of mechanical ventilation
timeFrame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
measure: Number and rate of patients with organ involvement (complications)
timeFrame: From date of hospitalization until date of discharge or death, whichever came first, assessed up to 365 days
measure: Number and rate of patients with COVID-19-related long-term effects assessed by EQ-5D-3L questionnaire
timeFrame: From date of hospitalization until day 365 after recruitment
measure: Number and rate of patients with changes in quality of life, assessed by EQ-5D-3L questionnaire
timeFrame: From date one month before study enrolement in hospital until day 365 after recruitment
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikukm GmbH, Med Campus III
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III
city: Leipzig
country: Germany
facility: Klinik St. Georg gGmbH; Klinik für Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Medizinische Klinik II - Bereich Pneumologie
Study officials:
affiliation: Charite University
name: Martin Witzenrath, MD
role: PRINCIPAL_INVESTIGATOR
References: