Covid19NCT04747366
Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 (COVID-19), Including Chronic Morbidity
An observational study of Covid19, run by Charite University, Berlin, Germany at 11 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 750 participants
- Where
- 11 sitesGermany
- Study dates
- 6 Nov 2020to 30 Nov 2025
- How long will I take part?
- 36 Months
- 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
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Refusal to participate by patient, or appropriate legal representative
- Any condition that prohibits supplemental blood-sampling beyond routine blood drawing
Trial locations and contacts
11 sites in 1 country.
Florian Kurth, PD Dr. contact
11 sites in 1 country
Germany11 sites, 11 recruiting
- Recruiting
Charité University Hospital Berlin Medical Clinic Infectiology and Pneumology CCM/CVK
Berlin, 13353
Martin Witzenrath, Prof. Dr. med., +49 30 450 553 892, martin.witzenrath@charite.de
- Recruiting
University Hospital Cologne Internal Medicine I and Hematology and Oncology, Infectiology, additional qualification in Emergency Medicine
Cologne, North Rhine-Westphalia, 50937
Philipp Koehler, Dr. med., +49 221 478 85523, philipp.koehler@uk-koeln.de
- Recruiting
University Hospital Frankfurt Medical Clinic II Department of infectiology
Frankfurt am Main, Hesse, 60590
Maria Vehreschild, Prof., +49 69 6301 5452, Maria.Vehreschild@kgu.de
- Recruiting
University Medical Center Freiburg Department of Internal Medicine II Department of Infectiology
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Siegbert Rieg, Prof., +49 761 270 18240, siegbert.rieg@uniklinik-freiburg.de
- Recruiting
University Hospital Giessen (+Marburg) Medical Clinic II Pneumology and internal intensive care medicine Infectiology, Gastroenterology, Nephrology
Giessen, Hesse, 35392
Werner Seeger, Prof., +49 641 985 42350, werner.seeger@innere.med.uni.giessen.de
- Recruiting
Hanover Medical School Clinic for Pneumology
Hanover, Lower Saxony, 30625
Marius M Hoeper, Prof. Dr. med., +49 511 532 3531, Hoeper.marius@mh-hannover.de
- Recruiting
University Hospital Heidelberg Clinic for Gastroenterology, Infections, Poisoning
Heidelberg, Baden-Wurttemberg, 69120
Uta Merle, Prof. Dr. med., +49 6221 56 8611, Uta.Merle@med.uni-heidelberg.de
- Recruiting
University Hospital Jena Department of Internal Medicine IV
Jena, Thuringia, 07747
Philipp Reuken, PD Dr., +49 3641 9 324401, Philipp.Reuken@med.uni-jena.de
- Recruiting
University Medical Center Schleswig-Holstein (Campus Kiel): Internal medicine, gastroenterology, pneumology, allergology, sleep medicine, emergency medicine, intensive care
Kiel, Schleswig-Holstein, 24105
Rainer Noth, Dr. med., +49 431 500 22233, Rainer.Noth@uksh.de
- Recruiting
University Medical Center Schleswig-Holstein (Campus Lübeck): Internal medicine, gastroenterology, pneumology, allergology, sleep medicine, emergency medicine, intensive care
Lübeck, Schleswig-Holstein, 23538
Daniel Droemann, PD Dr., +49451 500 45000, Daniel.Droemann@uksh.de
- Recruiting
Clinic of the University of Munich Medical Clinic and Polyclinic III
Munich, Bavaria, 81377
Michael von Bergwelt, Prof. Dr., +49 89 4400 75551, michael.bergwelt-baildon@med.uni-muenchen.de
About this study
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
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.
Read more
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).
- Conditions
- Covid19
- Keywords
- COVID-19, coronavirus, SARS-CoV-2, cohort, observational, phenotyping, NAPKON-HAP, NAPKON, chronic morbidity, pa-covid
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire
Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the Short Form Health 36 (Sf36)
Health related quality of life after hospital discharge will be assessed with the questionnaire Short Form Health 36 (Sf36)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the Patient-Reported Outcomes Measurement Information System (PROMIS Profile)
Health related quality of life after hospital discharge will be assessed with the questionnaire Patient-Reported Outcomes Measurement Information System (PROMIS Profile)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the Neuropathy Questionnaire (Mnsi)
Health related quality of life after hospital discharge will be assessed with the questionnaire Neuropathy Questionnaire (Mnsi)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the Trauma Patient Health Questionnaire
Health related quality of life after hospital discharge will be assessed with the questionnaire Trauma Patient Health Questionnaire
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
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).
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.
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the National Eye Institute Visual Function Questionnaire (NEI-VFQ)
Health related quality of life after hospital discharge will be assessed with the questionnaire National Eye Institute Visual Function Questionnaire (NEI-VFQ)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in Patient-reported Quality of life recorded with the help of the St. George's Respiratory Questionnaire (SGRQ)
Health related quality of life after hospital discharge will be assessed with the questionnaire St. George's Respiratory Questionnaire (SGRQ)
Measured: day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset
Changes in neruocognitive testing with Cambridge Neuropsychological Test Automated Battery (CANTAB)
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.
Measured: 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)
Changes in neruocognitive testing with Montreal Cognitive Assessment Test (MOCA)
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).
Measured: 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)
Changes in blood pressure measured during spiroergometry testing
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.
Measured: 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)
Changes in sensomotory testing with the questionnaire for peripheral neuropathy (Michigan Neuropathy Screening Instrument, MNSI)
The MNSI will be used to screen patients for peripheral neuropathy.
Measured: 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)
Changes in sensomotory testing with the questionnaire (painDETECT-questionnaire, pDQ)
PainDETECT will be used to screen patients for for neuropathic pain.
Measured: 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)
Changes in Quantitative sensory testing (QST)
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.
Measured: 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)
Changes in Point-of-care neurography
Point-of-care neuography measures nerve conduction using a point-of-care device (DPNcheck, Neurometrix Inc, USA).
Measured: 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)
Changes in pulmonary function assessed by body plethysmography
Body plethysmography will yield information on the static and dynamic lung volumes to assess obstructive and restrictive ventilation patterns.
Measured: 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)
Changes in pulmonary function assessed by single breath CO (carbon monoxide) diffusion capacity (DLCO)
The DLCO test provides a general assessment of the lungs' ability to take up oxygen from the inspiratory air and to release carbon dioxide.
Measured: 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)
Changes in heart rate measured with ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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)
Changes in the oxygen saturation of the blood measured during spiroergometry testing
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.
Measured: 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)
Changes in the total concentration of carbon dioxide (ctCO2) of the blood measured during spiroergometry testing
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.
Measured: 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)
Changes in the pH value of the blood measured during spiroergometry testing
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.
Measured: 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)
Changes in the bicarbonate content of the blood measured during spiroergometry testing
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.
Measured: 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)
Changes in the blood lactate levels during spiroergometry testing
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.
Measured: 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)
Changes in the partial pressure of carbon dioxide (pCO2) of the blood measured during spiroergometry testing
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.
Measured: 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)
Changes in heart rhythm type measured with ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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
Changes in time intervals of PQ measured with ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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)
Changes in time intervals of QRS measured with ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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)
Changes in time intervals of QT measured with ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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)
Deviations in the ST segment depicted with the use of ECG (Electrocardiogram) during spiroergometry testing
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.
Measured: 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)
Secondary outcomes (33)
Changes in body temperature
Assessment of the patient´s body temperature will be performed at all visits during the acute phase.
Measured: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks
Changes in blood pressure
Assessment of the patient´s blood pressure will be performed at all visits during the acute phase.
Measured: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks
Changes in heart rate
Assessment of the patient´s heart rate will be performed at all visits during the acute phase.
Measured: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks
Changes in breath frequency (respiratory rate)
Assessment of the patient´s breath frequency (respiratory rate) will be performed at all visits during the acute phase.
Measured: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks
Changes in peripheral oxygen saturation
Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase.
Measured: every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks
Changes in the clinical score SOFA (sequential organ failure assessment)
At each study visit on the ICU ward, the SOFA score will be assessed (if provided in the clinical information system).
Measured: at primary admission to hospital, upon admission to ICU ward, every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score Berlin ARDS (acute respiratory distress syndrome) severity score (if provided)
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).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score APACHE (Acute Physiology and Chronic Health Evaluation) Score
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).
Measured: upon admission to ICU
Changes in the clinical score NEWS (National Early Warning Score)
At primary admission to hospital NEWS (National Early Warning Score) will be assessed (if provided in the clinical information system).
Measured: day 1 of enrollment in the study (day of hospitalization), if available
Changes in the clinical score qSOFA Score (quick sequential organ failure assessment)
At primary admission to hospital qSOFA Score will be assessed (if provided in the clinical information system).
Measured: day 1 of enrollment in the study (day of hospitalization), if available
Changes in the Barthel Index
The changes in the Barthel Index score will be recorded and evaluated, if provided.
Measured: 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
Changes in the Frailty score
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).
Measured: 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
Changes in the clinical score Murray Score
At each study visit on ICU ward the Murray Score will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score Glasgow Coma Scale (GCS)
At each study visit on ICU ward the Glasgow Coma Scale score will be assessed (if provided in the clinical information system).
Measured: upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks
Changes in the clinical score RASS (Richmond Agitation Sedation Scale)
At each study visit on ICU ward the RASS (Richmond Agitation Sedation Scale)will be assessed (if provided in the clinical information system).
Measured: upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks
Changes in the clinical score CAM-ICU (Score Confusion Assessment Method for Intensive Care Unit)
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).
Measured: every Monday, Wednesday and Friday during ICU ward stay,assessed up to 100 weeks
Changes in the clinical score SAPSII (Simplified acute physiology Score II)
At each study visit on ICU ward the SAPSII (Simplified acute physiology Score II) will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score NRS (numeric rating scale) pain score
At each study visit on ICU ward the NRS (numeric rating scale) pain score will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score BPS (behavioural pain scale) pain score
At each study visit on ICU ward the BPS (behavioural pain scale) pain score will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score CPOT (Critical Care Pain Observation tool)
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).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the clinical score DDS (Delirium detection score)
At each study visit on ICU ward the DDS (Delirium detection score) will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the checked items on the ICDSC (Intensive Care Delirium Screening checklist)
At each study visit on ICU ward the ICDSC (Intensive Care Delirium Screening checklist) will be assessed (if provided in the clinical information system).
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the heart time volume
Assessment of the patient´s heart time volume will be performed at all visits during their stay in the ICU ward.
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the cardiac index
Assessment of the patient´s cardiac index will be performed at all visits during their stay in the ICU ward.
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in EVLWI (Extravascular Lung Water Index)
Assessment of the patient´s Extravascular Lung Water Index measurement will be performed at all visits during their stay in the ICU ward.
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in Systemic Vascular Resistance Index (SVRI)
Assessment of the patient´s Systemic Vascular Resistance Index (SVRI) measurement will be performed at all visits during their stay in the ICU ward.
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in ITBVI (Intrathoracic Blood Volume Index)
Assessment of the patient´s ITBVI (Intrathoracic Blood Volume Index) measurement will be performed at all visits during their stay in the ICU ward.
Measured: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the score WHO (World Health Organisation) clinical ordinal scale
Changes in the patient´s score on the WHO clinical ordinal scale, used to measure illness severity over time will be assessed.
Measured: 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 NYHA (New York Heart Association) score
The changes in the NYHA (New York Heart Association) score will be recorded and evaluated, if provided.
Measured: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)
Changes in the Post-COVID-19 Functional Status (PCFS) scale
The changes in the Post-COVID-19 Functional Status (PCFS) scale will be recorded and evaluated, if provided.
Measured: at follow-up visits (3, 12, 24 and 36 months after symptom onset)
Changes in the National Institutes of Health Stroke Scale (NIHSS)
The changes in the National Institutes of Health Stroke Scale (NIHSS) will be recorded and evaluated, if provided.
Measured: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)
Changes in the Katz Index
The changes in the Katz Index will be recorded and evaluated, if provided.
Measured: at follow-up visits (3, 12, 24 and 36 months after symptom onset)
Changes in the Rose Dyspnea Scale
The changes in the Rose Dyspnea Scale will be recorded and evaluated, if provided.
Measured: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start6 Nov 2020
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 750 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Network University Medicine NUM, Berlin Institute of Health
- Responsible party
- Principal investigator, Prof. Dr. med. Martin Witzenrath, Charite University, Berlin, Germany
- Investigators
- Martin Witzenrath, Prof. Dr. med., Principal investigator, Charite University Hospital Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747366
- Sponsor's protocol ID
- NAPKON-HAP
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Hartung TJ, Steigerwald F, Romanello A, Kodde C, Endres M, Frank S, Heuschmann P, Koehler P, Krohn S, Pape D, Schaller J, Stocklein S, Vadasz I, Vehreschild J, Witzenrath M, Zoller T, Finke C; NAPKON Study Group. Post-COVID Fatigue Is Associated With Reduced Cortical Thickness After Hospitalization. Ann Clin Transl Neurol. 2026 Apr;13(4):755-766. doi: 10.1002/acn3.70260. Epub 2025 Nov 25.
PubMed 41288256Appel KS, Lee CH, Nunes de Miranda SM, Maier D, Reese JP, Anton G, Bahmer T, Ballhausen S, Balzuweit B, Bellinghausen C, Blumentritt A, Brechtel M, Chaplinskaya-Sobol I, Erber J, Fiedler K, Geisler R, Heyder R, Illig T, Kohls M, Kollek J, Krist L, Lorbeer R, Miljukov O, Mitrov L, Nurnberger C, Pape C, Pley C, Schafer C, Schaller J, Schattschneider M, Scherer M, Schulze N, Stahl D, Stubbe HC, Tamminga T, Tebbe JJ, Vehreschild MJGT, Wiedmann S, Vehreschild JJ. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation. Sci Rep. 2024 Jun 13;14(1):13607. doi: 10.1038/s41598-024-63945-5.
PubMed 38871878Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brunn C, Dhillon C, Fiessler C, Geisler R, Hamelmann E, Hansch S, Hanses F, Hanss S, Herold S, Heyder R, Hofmann AL, Putz SM, Horn A, Jakob C, Jiru-Hillmann S, Keil T, Khodamoradi Y, Kohls M, Kraus M, Krefting D, Kunze S, Kurth F, Lieb W, Lippert LJ, Lorbeer R, Lorenz-Depiereux B, Maetzler C, Miljukov O, Nauck M, Pape D, Puntmann V, Reinke L, Rommele C, Rudolph S, Sass J, Schafer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Stork S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethum K, Vadasz I, Valentin H, Wiedmann S, Zoller T, Nagel E, Krawczak M, von Kalle C, Illig T, Schreiber S, Witzenrath M, Heuschmann P, Vehreschild JJ; NAPKON Research Group. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics. Eur J Epidemiol. 2022 Aug;37(8):849-870. doi: 10.1007/s10654-022-00896-z. Epub 2022 Jul 29.
PubMed 35904671
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04747366
- Acronym / sponsor ID
- NAPKON-HAP
- Conditions
- Covid19
- Keywords
- COVID-19, coronavirus, SARS-CoV-2, cohort, observational, phenotyping, NAPKON-HAP, NAPKON
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Network University Medicine NUM, Berlin Institute of Health
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Feb 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to participate by patient, or appropriate legal representative
- Any condition that prohibits supplemental blood-sampling beyond routine blood drawing
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
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)
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)
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)
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)
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
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.
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)
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)
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
33 secondary outcomes
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
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
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
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
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
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
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
Changes in the clinical score APACHE (Acute Physiology and Chronic Health Evaluation) Score
Time frame: upon admission to ICU
Changes in the clinical score NEWS (National Early Warning Score)
Time frame: day 1 of enrollment in the study (day of hospitalization), if available
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
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
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
Changes in the clinical score Murray Score
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
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
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
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
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
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
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
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
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
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
Changes in the heart time volume
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in the cardiac index
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in EVLWI (Extravascular Lung Water Index)
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in Systemic Vascular Resistance Index (SVRI)
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
Changes in ITBVI (Intrathoracic Blood Volume Index)
Time frame: every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks
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 NYHA (New York Heart Association) score
Time frame: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)
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)
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)
Changes in the Katz Index
Time frame: at follow-up visits (3, 12, 24 and 36 months after symptom onset)
Changes in the Rose Dyspnea Scale
Time frame: at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 41288256Hartung TJ, Steigerwald F, Romanello A, Kodde C, Endres M, Frank S, Heuschmann P, Koehler P, Krohn S, Pape D, Schaller J, Stocklein S, Vadasz I, Vehreschild J, Witzenrath M, Zoller T, Finke C; NAPKON Study Group. Post-COVID Fatigue Is Associated With Reduced Cortical Thickness After Hospitalization. Ann Clin Transl Neurol. 2026 Apr;13(4):755-766. doi: 10.1002/acn3.70260. Epub 2025 Nov 25.
- Derived from this study: PubMed 38871878Appel KS, Lee CH, Nunes de Miranda SM, Maier D, Reese JP, Anton G, Bahmer T, Ballhausen S, Balzuweit B, Bellinghausen C, Blumentritt A, Brechtel M, Chaplinskaya-Sobol I, Erber J, Fiedler K, Geisler R, Heyder R, Illig T, Kohls M, Kollek J, Krist L, Lorbeer R, Miljukov O, Mitrov L, Nurnberger C, Pape C, Pley C, Schafer C, Schaller J, Schattschneider M, Scherer M, Schulze N, Stahl D, Stubbe HC, Tamminga T, Tebbe JJ, Vehreschild MJGT, Wiedmann S, Vehreschild JJ. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation. Sci Rep. 2024 Jun 13;14(1):13607. doi: 10.1038/s41598-024-63945-5.
- Derived from this study: PubMed 35904671Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brunn C, Dhillon C, Fiessler C, Geisler R, Hamelmann E, Hansch S, Hanses F, Hanss S, Herold S, Heyder R, Hofmann AL, Putz SM, Horn A, Jakob C, Jiru-Hillmann S, Keil T, Khodamoradi Y, Kohls M, Kraus M, Krefting D, Kunze S, Kurth F, Lieb W, Lippert LJ, Lorbeer R, Lorenz-Depiereux B, Maetzler C, Miljukov O, Nauck M, Pape D, Puntmann V, Reinke L, Rommele C, Rudolph S, Sass J, Schafer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Stork S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethum K, Vadasz I, Valentin H, Wiedmann S, Zoller T, Nagel E, Krawczak M, von Kalle C, Illig T, Schreiber S, Witzenrath M, Heuschmann P, Vehreschild JJ; NAPKON Research Group. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics. Eur J Epidemiol. 2022 Aug;37(8):849-870. doi: 10.1007/s10654-022-00896-z. Epub 2022 Jul 29.
- Individual participant dataSharing planned: No. 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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Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Florian Kurth, PD Dr. contact
Martin Witzenrath, Prof. Dr. med. principal investigator
Charite University Hospital Berlin
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Charite University, Berlin, Germany at 11 sites in Germany.
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 4 inclusion and 2 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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?
Contact Martin Witzenrath, Prof. Dr. med. (+49 30 450 553 892, martin.witzenrath@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747366, which also lists 3 linked publications.
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 10 Feb 2021.