Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747366
Status:
RECRUITING
Last Update Posted:
2021-02-10
First Post:
2021-01-20
Brief Title:
Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 COVID-19 Including Chronic Morbidity
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
National Pandemic Cohort Network - High-resolution Platform HAP Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 COVID-19 Including Chronic Morbidity
Status:
RECRUITING
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NAPKON-HAP is the deep phenotyping platform of the National Pandemic Cohort Network NAPKON in Germany NAPKON is a data and biospecimen collection of patients with COVID-19 and is part of the University Medicine Network NUM in Germany The primary objective of the study is to provide a comprehensive collection of data and biosamples for researchers from national consortia and for participation in international research collaborations for studying COVID-19 and future pandemics
Data is collected from patients with COVID-19 three times per week during their hospitalization and at follow-up visits after hospital discharge 3 6 12 24 and 36 months after symptom onset Data include epidemiological and demographic parameters medical history and potential risk factors documentation of routine medical procedures and clinical course including different patterns of organ involvement quality of care morbidity and quality of life Moreover extensive serial high-quality bio sampling consisting of various sample types is performed to allow deep molecular immunological and virological phenotyping
Patients not requiring Intensive Care Unit ICU Intermediate Care IMC treatment will receive 7 and patients requiring ICUIMC treatment will receive 16 full-phenotyping visits including sampling for biobanking During hospitalisation the planned blood sampling rate in total is 35 ml at each visit The total amounts andor sampling dates may differ according to the ethics committees regulations for different study centers
At follow-up visits the clinical assessment includes an update of the medical history and recent medical events from which additional clinical data is collected ie outpatient CT-scans echocardiography external laboratory data Clinical symptoms are recorded and a physical examination will be performed Vital signs are recorded and routine blood testing and biosampling is continued Quality of life is measured with patient-reported outcome questionnaires
Follow-up visits at months 3 and 12 are deep phenotyping visits with a comprehensive and detailed set of examinations In the following visits at months 24 and 36 only examinations with pathologic results from the last deep phenotyping visit at month 12 will be performed
A shorter follow-up visit to record quality of life recent medical events and with a reduced number of examinations focusing on cardiorespiratory performance will take place at month 6
In case of relevant medical events new medical information or changes in the participants health status an unscheduled visit can take place anytime within the entire study period
Data collection during follow up includes standardized quality of life assessment including PROMIS Patient-Reported Outcomes Measurement Information System The pulmonary characterization will include body plethysmography diffusion capacity respiratory muscles strength measurement spiroergometry capillary blood gas analysis and lung imaging studies low-dose Computed Tomography CT Magnetic Resonance Imaging MRI of the lung Cardiological phenotyping includes echocardiography electrocardiogram ECG 24h-ECG 24h-blood pressure monitoring stress cardiac MRI and pulse wave analysis Neurocognitive testing includes brain MRI electroencephalogram EEG somatosensory testing refractometry Visit 3 and 12 months physical activity test neurocognitive tests somatosensory phenotyping taste- and smell-test Endocrinological phenotyping will incorporate Advanced Glycation Endproducts AGE reader continuous glucose monitoring for 14 days Air Displacement Plethysmography ADP or bioelectrical impedance analysis BIA
Data is collected from patients with COVID-19 three times per week during their hospitalization and at follow-up visits after hospital discharge 3 6 12 24 and 36 months after symptom onset Data include epidemiological and demographic parameters medical history and potential risk factors documentation of routine medical procedures and clinical course including different patterns of organ involvement quality of care morbidity and quality of life Moreover extensive serial high-quality bio sampling consisting of various sample types is performed to allow deep molecular immunological and virological phenotyping
Patients not requiring Intensive Care Unit ICU Intermediate Care IMC treatment will receive 7 and patients requiring ICUIMC treatment will receive 16 full-phenotyping visits including sampling for biobanking During hospitalisation the planned blood sampling rate in total is 35 ml at each visit The total amounts andor sampling dates may differ according to the ethics committees regulations for different study centers
At follow-up visits the clinical assessment includes an update of the medical history and recent medical events from which additional clinical data is collected ie outpatient CT-scans echocardiography external laboratory data Clinical symptoms are recorded and a physical examination will be performed Vital signs are recorded and routine blood testing and biosampling is continued Quality of life is measured with patient-reported outcome questionnaires
Follow-up visits at months 3 and 12 are deep phenotyping visits with a comprehensive and detailed set of examinations In the following visits at months 24 and 36 only examinations with pathologic results from the last deep phenotyping visit at month 12 will be performed
A shorter follow-up visit to record quality of life recent medical events and with a reduced number of examinations focusing on cardiorespiratory performance will take place at month 6
In case of relevant medical events new medical information or changes in the participants health status an unscheduled visit can take place anytime within the entire study period
Data collection during follow up includes standardized quality of life assessment including PROMIS Patient-Reported Outcomes Measurement Information System The pulmonary characterization will include body plethysmography diffusion capacity respiratory muscles strength measurement spiroergometry capillary blood gas analysis and lung imaging studies low-dose Computed Tomography CT Magnetic Resonance Imaging MRI of the lung Cardiological phenotyping includes echocardiography electrocardiogram ECG 24h-ECG 24h-blood pressure monitoring stress cardiac MRI and pulse wave analysis Neurocognitive testing includes brain MRI electroencephalogram EEG somatosensory testing refractometry Visit 3 and 12 months physical activity test neurocognitive tests somatosensory phenotyping taste- and smell-test Endocrinological phenotyping will incorporate Advanced Glycation Endproducts AGE reader continuous glucose monitoring for 14 days Air Displacement Plethysmography ADP or bioelectrical impedance analysis BIA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None