NCT04747366

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

Status unknown Last updated 10 February 2021

What this trial tests

trial in Covid19 in 750 participants. Status unknown.

Timeline

6 November 2020

Primary endpoint
1 November 2025

30 November 2025

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	750
Start date	6 November 2020
Primary completion	1 November 2025
Estimated completion	30 November 2025
Sites	11 locations across Germany

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.
   Schons M, Pilgram L, Reese JP, Stecher M, et al · · 2022 · cited 44× · PMID 35904671 · DOI 10.1007/s10654-022-00896-z
2. Different Impacts on the Heart After COVID-19 Infection and Vaccination: Insights From Cardiovascular Magnetic Resonance.
   Gröschel J, Bhoyroo Y, Blaszczyk E, Trauzeddel RF, et al · · 2022 · cited 9× · PMID 35911510 · DOI 10.3389/fcvm.2022.916922
3. Analysis of acute COVID-19 including chronic morbidity: protocol for the deep phenotyping National Pandemic Cohort Network in Germany (NAPKON-HAP).
   Steinbeis F, Thibeault C, Steinbrecher S, Ahlgrimm Y, et al · · 2024 · cited 2× · PMID 37434025 · DOI 10.1007/s15010-023-02057-0
4. Half-Dose versus Single-Dose Gadobutrol for Extracellular Volume Measurements in Cardiac Magnetic Resonance.
   Doeblin P, Steinbeis F, Witzenrath M, Hashemi D, et al · · 2023 · cited 1× · PMID 37623329 · DOI 10.3390/jcdd10080316
5. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.
   Schons MJ, Pilgram L, Reese J, Stecher M, et al · · 2022 · cited 1× · DOI 10.21203/rs.3.rs-1249111/v1
6. Post-COVID Fatigue Is Associated With Reduced Cortical Thickness After Hospitalization.
   Hartung TJ, Steigerwald F, Romanello A, Kodde C, et al · · 2026 · PMID 41288256 · DOI 10.1002/acn3.70260
7. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation.
   Appel KS, Lee CH, Nunes de Miranda SM, Maier D, et al · · 2024 · PMID 38871878 · DOI 10.1038/s41598-024-63945-5