Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04977934 |
| Other study ID # |
PROVID-PROGRESS |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2021 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Charite University, Berlin, Germany |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
