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Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 (COVID-19), Including Chronic Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747366
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborators:
Network University Medicine NUM
Berlin Institute of Health
Information provided by (Responsible Party):
Prof. Dr. med. Martin Witzenrath, Charite University, Berlin, Germany

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 ICU/IMC 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 and/or sampling dates may differ according to the ethics committee's 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 (i.e. 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 participant´s 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).


Condition or disease
Covid19

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
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
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l)

  2. Changes in Patient-reported Quality of life recorded with the help of the Short Form Health 36 (Sf36) [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire Short Form Health 36 (Sf36)

  3. Changes in Patient-reported Quality of life recorded with the help of the Patient-Reported Outcomes Measurement Information System (PROMIS Profile) [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire Patient-Reported Outcomes Measurement Information System (PROMIS Profile)

  4. Changes in Patient-reported Quality of life recorded with the help of the Neuropathy Questionnaire (Mnsi) [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire Neuropathy Questionnaire (Mnsi)

  5. Changes in Patient-reported Quality of life recorded with the help of the Trauma Patient Health Questionnaire [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire Trauma Patient Health Questionnaire

  6. Changes in Patient-reported Quality of life recorded with the help of the PTSD (Post-traumatic stress disorder) Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the PTSD (Post-traumatic stress disorder) Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). The PTSD Checklist for DSM-5 is a 20-questions self-report measure that assesses the presence and severity of PTSD symptoms.

  7. Changes in Patient-reported Quality of life recorded with the help of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire National Eye Institute Visual Function Questionnaire (NEI-VFQ)

  8. Changes in Patient-reported Quality of life recorded with the help of the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset ]
    Health related quality of life after hospital discharge will be assessed with the questionnaire St. George's Respiratory Questionnaire (SGRQ)

  9. Changes in neruocognitive testing with Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    CANTAB tests can detect changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.

  10. Changes in neruocognitive testing with Montreal Cognitive Assessment Test (MOCA) [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    This test is a screening procedure to determine cognitive deficits. Central cognitive functions are examined using 11 task complexes. This includes time and spatial orientation, learning and memory, attention, language and language skills, reading, writing, drawing and calculating (test duration approx. 10 minutes).

  11. Changes in blood pressure measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Using spiroergometry blood pressure is measured during the test and compared with normative values.

  12. Changes in sensomotory testing with the questionnaire for peripheral neuropathy (Michigan Neuropathy Screening Instrument, MNSI) [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    The MNSI will be used to screen patients for peripheral neuropathy.

  13. Changes in sensomotory testing with the questionnaire (painDETECT-questionnaire, pDQ) [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    PainDETECT will be used to screen patients for for neuropathic pain.

  14. Changes in Quantitative sensory testing (QST) [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Quantitative sensory testing (QST) is a method for semiquantative evaluation of somatosensory nervous system disorders, including chronic pain and pain related to various diseases. It essentially determines the sensation and pain thresholds for cold and warm temperatures, and the vibration sensation threshold by stimulating the skin and comparing the results to normative values.

  15. Changes in Point-of-care neurography [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Point-of-care neuography measures nerve conduction using a point-of-care device (DPNcheck, Neurometrix Inc, USA).

  16. Changes in pulmonary function assessed by body plethysmography [ Time Frame: immediately before discharge, at follow-up visits (3, 6 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Body plethysmography will yield information on the static and dynamic lung volumes to assess obstructive and restrictive ventilation patterns.

  17. Changes in pulmonary function assessed by single breath CO (carbon monoxide) diffusion capacity (DLCO) [ Time Frame: immediately before discharge, at follow-up visits (3, 6 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    The DLCO test provides a general assessment of the lungs' ability to take up oxygen from the inspiratory air and to release carbon dioxide.

  18. Changes in heart rate measured with ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The patient´s heart rate will be assessed longitudinally and compared to normative values.

  19. Changes in the oxygen saturation of the blood measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The total concentration of carbon dioxide (ctCO2) of the blood is measured and compared with normative values.

  20. Changes in the total concentration of carbon dioxide (ctCO2) of the blood measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. The carbon dioxide content of the blood is measured during the test and compared with normative values.

  21. Changes in the pH value of the blood measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The pH value of the blood is measured and compared with normative values. The pH value describes how acidic or basic the blood is.

  22. Changes in the bicarbonate content of the blood measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The bicarbonate content of the blood is measured and compared with normative values. Bicarbonate is a form of carbon dioxide.

  23. Changes in the blood lactate levels during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The lactate saturation is measured and compared with normative values.

  24. Changes in the partial pressure of carbon dioxide (pCO2) of the blood measured during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The partial pressure of carbon dioxide (pCO2) of the blood is measured and compared with normative values.

  25. Changes in heart rhythm type measured with ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The patient´s heart rhythm will be assessed. Any abnormalities (too slow, too fast, irregular) will be documented and subsequently clinical consequences are being taken.

  26. Changes in time intervals of PQ measured with ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The time interval of PQ corresponds to the time interval from the beginning of the P wave to the beginning of the Q wave of the QRS complex. The time interval of PQ gives us information about the time required for the action potential to be transmitted from the atria to the ventricles. The recorded PQ time will be compared to normative values. In case of delayed PQ times, further diagnostic is carried out according to current guidelines.

  27. Changes in time intervals of QRS measured with ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The QRS complex is combination of the Q wave, R wave and S wave. The time interval of QRS corresponds to the time needed for ventricular depolarization. The recorded QRS time will be compared to normative values. In case of new diagnosed bundle blocks, further diagnostic is carried out according to current guidelines.

  28. Changes in time intervals of QT measured with ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The time interval of QT corresponds to the time interval from the beginning of the Q wave to the end of the T wave. The time interval of QT gives us information about the time required for ventricular depolarisation and repolarisation. The recorded QT time will be compared to normative values. In case of abnormal QT times, further diagnostic is carried out according to current guidelines.

  29. Deviations in the ST segment depicted with the use of ECG (Electrocardiogram) during spiroergometry testing [ Time Frame: at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results) ]
    Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The ST-segment is a section between the end of the S wave and the beginning of the T wave and reflects the depolarized state and initial repolarization of the ventricles. Deviations in the ST segment (elevation or depression) will be documented. In case of ST segment elevation or depression, further diagnostic is carried out according to current guidelines.


Secondary Outcome Measures :
  1. Changes in body temperature [ Time Frame: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks ]
    Assessment of the patient´s body temperature will be performed at all visits during the acute phase.

  2. Changes in blood pressure [ Time Frame: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks ]
    Assessment of the patient´s blood pressure will be performed at all visits during the acute phase.

  3. Changes in heart rate [ Time Frame: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks ]
    Assessment of the patient´s heart rate will be performed at all visits during the acute phase.

  4. Changes in breath frequency (respiratory rate) [ Time Frame: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks ]
    Assessment of the patient´s breath frequency (respiratory rate) will be performed at all visits during the acute phase.

  5. Changes in peripheral oxygen saturation [ Time Frame: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks ]
    Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase.

  6. Changes in the clinical score SOFA (sequential organ failure assessment) [ Time Frame: at primary admission to hospital, upon admission to ICU ward, every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on the ICU ward, the SOFA score will be assessed (if provided in the clinical information system).

  7. Changes in the clinical score Berlin ARDS (acute respiratory distress syndrome) severity score (if provided) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on the ICU ward, the Berlin ARDS (acute respiratory distress syndrome) severity score will be assessed (if provided in the clinical information system).

  8. Changes in the clinical score APACHE (Acute Physiology and Chronic Health Evaluation) Score [ Time Frame: upon admission to ICU ]
    At each study visit on the ICU ward, the APACHE (Acute Physiology and Chronic Health Evaluation) score will be assessed (if provided in the clinical information system).

  9. Changes in the clinical score NEWS (National Early Warning Score) [ Time Frame: day 1 of enrollment in the study (day of hospitalization), if available ]
    At primary admission to hospital NEWS (National Early Warning Score) will be assessed (if provided in the clinical information system).

  10. Changes in the clinical score qSOFA Score (quick sequential organ failure assessment) [ Time Frame: day 1 of enrollment in the study (day of hospitalization), if available ]
    At primary admission to hospital qSOFA Score will be assessed (if provided in the clinical information system).

  11. Changes in the Barthel Index [ Time Frame: day 1 of enrollment in the study, every Monday, Wednesday and Friday during hospitalisation, (assessed up to 100 weeks?), immediately before discharge, at follow up visits 3, 12, 24 and 36 months after symptom onset ]
    The changes in the Barthel Index score will be recorded and evaluated, if provided.

  12. Changes in the Frailty score [ Time Frame: day 1 of enrollment in the study, every Monday, Wednesday and Friday during hospitalisation, (assessed up to 100 weeks?), immediately before discharge, at follow up visits 3, 12, 24 and 36 months after symptom onset ]
    At each study visit during hospitalization (visits are conducted 3 times a week until discharge) the Frailty score will be assessed (if provided in the clinical information system).

  13. Changes in the clinical score Murray Score [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the Murray Score will be assessed (if provided in the clinical information system).

  14. Changes in the clinical score Glasgow Coma Scale (GCS) [ Time Frame: upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the Glasgow Coma Scale score will be assessed (if provided in the clinical information system).

  15. Changes in the clinical score RASS (Richmond Agitation Sedation Scale) [ Time Frame: upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the RASS (Richmond Agitation Sedation Scale)will be assessed (if provided in the clinical information system).

  16. Changes in the clinical score CAM-ICU (Score Confusion Assessment Method for Intensive Care Unit) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay,assessed up to 100 weeks ]
    At each study visit on ICU ward the CAM-ICU (Score Confusion Assessment Method for Intensive Care Unit) score will be assessed (if provided in the clinical information system).

  17. Changes in the clinical score SAPSII (Simplified acute physiology Score II) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the SAPSII (Simplified acute physiology Score II) will be assessed (if provided in the clinical information system).

  18. Changes in the clinical score NRS (numeric rating scale) pain score [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the NRS (numeric rating scale) pain score will be assessed (if provided in the clinical information system).

  19. Changes in the clinical score BPS (behavioural pain scale) pain score [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the BPS (behavioural pain scale) pain score will be assessed (if provided in the clinical information system).

  20. Changes in the clinical score CPOT (Critical Care Pain Observation tool) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the CPOT (Critical Care Pain Observation tool) score will be assessed (if provided in the clinical information system).

  21. Changes in the clinical score DDS (Delirium detection score) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the DDS (Delirium detection score) will be assessed (if provided in the clinical information system).

  22. Changes in the checked items on the ICDSC (Intensive Care Delirium Screening checklist) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    At each study visit on ICU ward the ICDSC (Intensive Care Delirium Screening checklist) will be assessed (if provided in the clinical information system).

  23. Changes in the heart time volume [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    Assessment of the patient´s heart time volume will be performed at all visits during their stay in the ICU ward.

  24. Changes in the cardiac index [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    Assessment of the patient´s cardiac index will be performed at all visits during their stay in the ICU ward.

  25. Changes in EVLWI (Extravascular Lung Water Index) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    Assessment of the patient´s Extravascular Lung Water Index measurement will be performed at all visits during their stay in the ICU ward.

  26. Changes in Systemic Vascular Resistance Index (SVRI) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    Assessment of the patient´s Systemic Vascular Resistance Index (SVRI) measurement will be performed at all visits during their stay in the ICU ward.

  27. Changes in ITBVI (Intrathoracic Blood Volume Index) [ Time Frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks ]
    Assessment of the patient´s ITBVI (Intrathoracic Blood Volume Index) measurement will be performed at all visits during their stay in the ICU ward.

  28. Changes in the score WHO (World Health Organisation) clinical ordinal scale [ Time Frame: every day during hospital stay (from day of admission until discharge from hospital, assessed up to 100 weeks) and at follow-up visits (3, 12, 24 and 36 months after symptom onset) ]
    Changes in the patient´s score on the WHO clinical ordinal scale, used to measure illness severity over time will be assessed.

  29. Changes in the NYHA (New York Heart Association) score [ Time Frame: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset) ]
    The changes in the NYHA (New York Heart Association) score will be recorded and evaluated, if provided.

  30. Changes in the Post-COVID-19 Functional Status (PCFS) scale [ Time Frame: at follow-up visits (3, 12, 24 and 36 months after symptom onset) ]
    The changes in the Post-COVID-19 Functional Status (PCFS) scale will be recorded and evaluated, if provided.

  31. Changes in the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset) ]
    The changes in the National Institutes of Health Stroke Scale (NIHSS) will be recorded and evaluated, if provided.

  32. Changes in the Katz Index [ Time Frame: at follow-up visits (3, 12, 24 and 36 months after symptom onset) ]
    The changes in the Katz Index will be recorded and evaluated, if provided.

  33. Changes in the Rose Dyspnea Scale [ Time Frame: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset) ]
    The changes in the Rose Dyspnea Scale will be recorded and evaluated, if provided.


Biospecimen Retention:   Samples With DNA
Saliva, Urin, Oropharyngeal / Nasopharyngeal swab / Bronchoalveolar lavage (BAL) / Endotracheal aspirate (ENTA), whole blood


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 patients, hospitalised at any of the participating hospitals (see study sites) over the age of 18 years, who are willing and deemed able to participate in the study
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Willingness to participate in the study (consent to participate by patient or appropriate legal representative) or inclusion via deferred consent
  • Hospitalization at time of enrollment
  • Positive evidence for SARS-CoV-2 infection with PCR (polymerase chain reaction) or initial positive rapid diagnostic test in conjunction with typical clinical symptoms, confirmed by a later positive PCR test.

Exclusion Criteria:

  • Refusal to participate by patient, or appropriate legal representative
  • Any condition that prohibits supplemental blood-sampling beyond routine blood drawing

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): NCT04747366


Contacts
Layout table for location contacts
Contact: Martin Witzenrath, Prof. Dr. med. +49 30 450 553 892 martin.witzenrath@charite.de
Contact: Florian Kurth, PD Dr. florian.kurth@charite.de

Locations
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Germany
University Medical Center Freiburg Department of Internal Medicine II Department of Infectiology Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Contact: Siegbert Rieg, Prof.    +49 761 270 18240    siegbert.rieg@uniklinik-freiburg.de   
University Hospital Heidelberg Clinic for Gastroenterology, Infections, Poisoning Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Uta Merle, Prof. Dr. med.    +49 6221 56 8611    Uta.Merle@med.uni-heidelberg.de   
Clinic of the University of Munich Medical Clinic and Polyclinic III Recruiting
Munich, Bayern, Germany, 81377
Contact: Michael von Bergwelt, Prof. Dr.    +49 89 4400 75551    michael.bergwelt-baildon@med.uni-muenchen.de   
University Hospital Frankfurt Medical Clinic II Department of infectiology Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Maria Vehreschild, Prof.    +49 69 6301 5452    Maria.Vehreschild@kgu.de   
University Hospital Giessen (+Marburg) Medical Clinic II Pneumology and internal intensive care medicine Infectiology, Gastroenterology, Nephrology Recruiting
Gießen, Hessen, Germany, 35392
Contact: Werner Seeger, Prof.    +49 641 985 42350    werner.seeger@innere.med.uni.giessen.de   
Hanover Medical School Clinic for Pneumology Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Marius M Hoeper, Prof. Dr. med.    +49 511 532 3531    Hoeper.marius@mh-hannover.de   
University Hospital Cologne Internal Medicine I and Hematology and Oncology, Infectiology, additional qualification in Emergency Medicine Recruiting
Cologne, Nordrhein-Westfalen, Germany, 50937
Contact: Philipp Koehler, Dr. med.    +49 221 478 85523    philipp.koehler@uk-koeln.de   
University Medical Center Schleswig-Holstein (Campus Kiel): Internal medicine, gastroenterology, pneumology, allergology, sleep medicine, emergency medicine, intensive care Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Rainer Noth, Dr. med.    +49 431 500 22233    Rainer.Noth@uksh.de   
University Medical Center Schleswig-Holstein (Campus Lübeck): Internal medicine, gastroenterology, pneumology, allergology, sleep medicine, emergency medicine, intensive care Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Daniel Droemann, PD Dr.    +49451 500 45000    Daniel.Droemann@uksh.de   
University Hospital Jena Department of Internal Medicine IV Recruiting
Jena, Thüringen, Germany, 07747
Contact: Philipp Reuken, PD Dr.    +49 3641 9 324401    Philipp.Reuken@med.uni-jena.de   
Charité University Hospital Berlin Medical Clinic Infectiology and Pneumology CCM/CVK Recruiting
Berlin, Germany, 13353
Contact: Martin Witzenrath, Prof. Dr. med.    +49 30 450 553 892    martin.witzenrath@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Network University Medicine NUM
Berlin Institute of Health
Investigators
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Principal Investigator: Martin Witzenrath, Prof. Dr. med. Charite University Hospital Berlin
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Responsible Party: Prof. Dr. med. Martin Witzenrath, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04747366    
Other Study ID Numbers: NAPKON-HAP
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Given a concrete inquiry and prior consent by the study participants in question, IPD (individual participant data) can be made available on a case by case basis.

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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
coronavirus
SARS-CoV-2
cohort
observational
phenotyping
NAPKON-HAP
NAPKON
chronic morbidity
pa-covid
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases