NAPKON - National Pandemic Cohort Network – Monkeypox Platform Analysis of pathophysiology and pathology of Monkeypox Virus (MPV), including chronic morbidity
Organizational Data
- DRKS-ID:
- DRKS00029147
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2022-08-17
- Last update in DRKS:
- 2023-01-31
- Registration type:
- Prospective
Acronym/abbreviation of the study
NAPKON - Monkeypox
URL of the study
Brief summary in lay language
Since May 2022, there has been the largest ever outbreak of monkeypox (MPV) outside the endemic areas in Africa. Since the beginning of May 2022, cases have been reported in the United Kingdom, Spain, Portugal and Germany, among other countries. Despite increasing evidence, there are still many unanswered questions about the pathophysiology of MPV, potential preventive and therapeutic targets, and chronic morbidity in survivors. This study will improve understanding of the epidemiology, consequences and pathomechanisms of the disease and provide important information and samples for researchers, clinicians and policy makers. The study is part of the National Pandemic Cohort Network (NAPKON), which implemented a research infrastructure for cohort studies within the Netzwerk Universitätsmedizin (NUM) that formed the basis for a permanent research infrastructure for best practice in clinical management for possible future pandemics in Germany.
Brief summary in scientific language
Since May 2022, the largest outbreak yet of monkeypox (MPV) outside of endemic areas in Africa is ongoing. WHO is calling for rigorous prosecution of all contacts by those affected. Despite growing evidence, there are still many open questions concerning the pathophysiology of MPV, potential preventive and therapeutic targets, and chronic morbidity of survivors. The current epidemic of MPV infection and the high rate of severe disease courses in previous outbreaks implies a special responsibility in assessing all available information from medical care and human biosamples. Therefore, nationwide patient data needs to be collected at the participating sites to enable fighting the outbreak of MPV infection in a systematic and effective way. This multicentric study will improve the understanding of disease epidemiology, outcomes, and pathomechanisms by harmonized deep phenotyping and comprehensive in-depth investigations on MPV infection and sequelae in a well-defined patient population and offers crucial information and samples for researchers, clinicians, and policy makers. With the National Pandemic Cohort Network (Nationales Pandemie Kohorten Netzwerk, NAPKON), a research infrastructure for cohort studies has been implemented within the University Medicine Network (Netzwerk Universitätsmedizin, NUM) to form the basis of a durable research infrastructure for best practice in clinical management applicable to possible future pandemics in Germany. This study will closely follow protocols established in the clinical platforms of NAPKON. The aim of the NAPKON Monkeypox Platform is to perform deep longitudinal clinical, molecular and immunological phenotyping in patients with MPV infection and to assess clinical outcomes and endpoints comprehensively.
Health condition or problem studied
- ICD10:
- B04 - Monkeypox
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients with confirmed MPV infection, Primary and secondary pathophysiological changes and organ function as well as clinical interventions and potential biomarkers and surrogate markers of infection will be documented and analysed. Scientific analyses will be performed on human biospecimens, such as blood and skin samples. The biospecimens are obtained during clinical diagnosis. During inpatient treatment, study visits will take place on three days per week (Monday/Wednesday/Friday). Follow-up examinations will be performed at a maximum of five time points (after 3 months, 6 months, 12 months, 24 months and 36 months). These include further biospecimen collection, patient interview and examination, and symptom survey. In addition, patients will be asked to complete relevant quality of life questionnaires (including PROMIS-29).
Endpoints
- Primary outcome:
- Following the principle of NAPKON as a data and biospecimen collection platform for the Netzwerk Universitätsmedizin NUM, a specific primary endpoint was not included. The primary objective of the NAPKON Monkeypox Platform is to provide a comprehensive and harmonized collection of data and biosamples for researchers from national consortia and for participation in international research collaborations for the purpose of studying MPV Infection.
- Secondary outcome:
- We specifically aim at generating hypotheses regarding: - Infection with MPV and its primary and secondary pathophysiologic changes of various organ systems and of the immune system - Association of severe disease course with organ failure - Modulation of innate immune system - Specific activation of the adaptive immune system - Analysis of MPV induced immune response and its change over time to identify biomarkers and develop therapeutic strategies - Detailed analysis of MPV induced adaptive (humoral and cellular) immune response to support the development of vaccines - Identification of inflammatory biomarkers for early estimation of disease progression and choice of therapeutic option - Combination of microbiologic and immunologic analyses to provide information on the role of bacterial superinfection in the pathophysiology of MPV - Analysis of viral and bacterial diversity, viral load to provide prognostic biomarkers for disease progression and infectiousness - Single cell multiomics analysis of patient material to provide insights into MPV infection to identify therapeutic targets - Integrative analysis of clinical parameters with molecular results to provide insight into MPV infection as well as the variability of the disease course, including possible predictors of health sequelae - Determine risk-factors, define clinical course of disease and investigate long-term sequelae in smallpox vaccine breakthrough infections - Epigenetic factors and impact on the clinical course of MPV infectio
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Frankfurt Frankfurt a.M.
- University medical center Charité - Universitätsmedizin Berlin Berlin
Recruitment period and number of participants
- Planned study start date:
- 2024-01-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Age ≥ 18 years, Willingness to participate in the study, Symptomatic MPV infection (e.g. rash, fever, or other signs and symptoms associated with MPV infection and without other more plausible cause), Consent within 14 days of symptom onset, Positive MPV PCR from blood or skin sample (swab or biopsy)
Exclusion Criteria
Any condition that prohibits supplemental blood-sampling beyond routine blood drawing
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Frankfurt, Medizinische Klinik 2Prof. Dr. med. Janne VehreschildTheodor-Stern-Kai 760590 Frankfurt am MainGermany
- Telephone:
- +49 69/6301-6103
- Fax:
- +49 69/6301-7960
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité - Universitätsmedizin Berlin, Med. Kl. m. S. Infektiologie und PneumologieProf. Dr. med. Martin WitzenrathCharitéplatz 110117 BerlinGermany
- Telephone:
- +49 30 450 553892
- Fax:
- +49 30 450 7553876
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://infektiologie-pneumologie.charite.de/
Contact for Public Queries
- Address:
- Charité - Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- +49 221 478-88794
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://napkon.de/
Principal Investigator
- Address:
- Charité - Universitätsmedizin Berlin, Med. Kl. m. S. Infektiologie und PneumologieProf. Dr. med. Martin WitzenrathCharitéplatz 110117 BerlinGermany
- Telephone:
- +49 30 450 553892
- Fax:
- +49 30 450 7553876
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://infektiologie-pneumologie.charite.de/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Frankfurt, Medizinische Klinik 2Theodor-Stern-Kai 760590 Frankfurt am MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Charité - Universitätsmedizin Berlin, Med. Kl. m. S. Infektiologie und PneumologieCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-06-10
- Ethics committee number:
- 2022-828-Prospektive Forschung erstberatend
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-08-04
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Access to samples and anonymised data for additional analyses will be governed by a Use & Access Committee composed of clinical principal investigators and the scientific investigators for this study
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry