Prospective molecular biological and serological examination for the detection of SARS-CoV-2 (COVID-19) in employees of a hospital of regular care in Germany
Organizational Data
- DRKS-ID:
- DRKS00021270
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-04-15
- Last update in DRKS:
- 2020-12-01
- Registration type:
- Retrospective
Acronym/abbreviation of the study
ProCoV
URL of the study
No Entry
Brief summary in lay language
There is no reliable data on the real spread of SARS-CoV-2 in the population. Representative studies would therefore be necessary. A representative population group could be all hospital employees, from cleaning staff to administrative staff to nurses and doctors. At least this would be a representative group of employees in the health service. All employees are included in this prospective observational study to detect SARS-CoV-2 by repeated molecular test and repetitive antibody test. This data will be correlated to a daily performed online survey. All data will be evaluated all 3 months to detect spreading pattern.
Brief summary in scientific language
There is no reliable data on the actual prevalence of SARS-CoV-2 in the population. Representative studies would therefore be necessary. A representative population group could be all hospital employees, from cleaning staff to administrative staff to nurses and doctors. At least this would be a representative group of healthcare workers. All employees are included in this prospective observational study to demonstrate SARS-CoV-2 through repeated molecular tests and repeated antibody tests. For this purpose, a weekly smear for PCR on SARS-CoV-2 and weekly antibody tests are carried out. In addition, blood samples are preserved for testing for seroconversion. This data is correlated with a daily online survey. All data are evaluated every 3 months to determine the spread pattern.
Health condition or problem studied
- ICD10:
- U07.1 - COVID-19, virus identified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- All employees at Reinbek Hospital are smeared weekly on COVID-19 and a blood sample is taken for the antibody test. At the same time, a daily online survey of the state of health takes place.
Endpoints
- Primary outcome:
- How many employees develop a COVID-19 positive test and how many develop antibodies in the sense of a seroconversion?
- Secondary outcome:
- Correlation between symptoms and positive test results Do certain groups show certain symptoms and certain courses?
Study Design
- Purpose:
- Screening
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Krankenhaus Reinbek St. Adolf-Stift Reinbek
Recruitment period and number of participants
- Planned study start date:
- 2020-04-14
- Actual study start date:
- 2020-04-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 900
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 16 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Actually working in the study center
Exclusion Criteria
No informed consent
Addresses
Primary Sponsor
- Address:
- Krankenhaus Reinbek St. Adolf-StiftBjörn PestingerHamburger Straße 4121465 ReinbekGermany
- Telephone:
- 00494072803300
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://krankenhaus-reinbek.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Krankenhaus Reinbek St. Adolf-StiftProf. Dr. med. Tim StrateHamburger Straße 4121465 ReinbekGermany
- Telephone:
- 00494072803300
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.krankenhaus-reinbek.de
Contact for Public Queries
- Address:
- Krankenhaus Reinbek St. Adolf-StiftDr. med. Jonas HerzbergHamburger Straße 4121465 ReinbekGermany
- Telephone:
- 00494072803300
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.krankenhaus-reinbek.de
Principal Investigator
- Address:
- Krankenhaus Reinbek St. Adolf-StiftProf. Dr. med. Tim StrateHamburger Straße 4121465 ReinbekGermany
- Telephone:
- 00494072803300
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.krankenhaus-reinbek.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Krankenhaus Reinbek St. Adolf-StiftHamburger Straße 4121465 ReinbekGermany
- Telephone:
- 00494072800
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://krankenhaus-reinbek.de
Ethics Committee
Address Ethics Committee
- Address:
- Ärztekammer Schleswig-Holstein, Ethik-KommissionBismarckallee 8-1223795 Bad SegebergGermany
- Telephone:
- +49-4551-803152
- Fax:
- +49-4551-803214
- 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:
- 2020-04-08
- Ethics committee number:
- 038/20 I
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-04-14
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?:
- No
- IPD Sharing Plan:
- Because of the use of high sensible health data, according to the ICMJE there will be no sharing of individual participant data at all. No other data in particular will be shared. The study protocol will be available. All other data will not be available.
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:
- Publikation im International Journal of Infectious Diseases
- 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