COVID-19NCT04405466
A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers
An observational study of COVID-19, run by Miltenyi Biomedicine GmbH at 1 site in Germany.
Trial summary
This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood sampling and Throat swab
- Type of treatment
- Surgery or procedure
- How many people
- 417 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2020to 17 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Workers
Who may be able to join
- Healthy workers asymptomatic for SARS-CoV-2
- Ability to consent with the study and its procedures
- Age above 18 years old
- Full time employee on site at least 3 full working days a week
- Working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas.
Who cannot join
- Workers presenting symptoms that could be signs of a SARS-CoV-2 infection such as:
- fever ≥38°C
- chills
- fatigue
- muscle ache (myalgia)
- sore throat
Show all 14Show fewer
- cough
- runny nose (rhinorrhea)
- shortness of breath (dyspnea)
- wheezing
- chest pain
- other respiratory Symptoms
- headache
- nausea/vomiting
Trial locations and contacts
1 site in 1 country.
Germany1 site
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach, North Rhine-Westphalia, 51429
About this study
Official title: A Prospective, Epidemiological, Cohort Study to Assess the Feasibility of Screening Healthy Asymptomatic Workers for the Presence of SARS-CoV-2 by Pharyngeal Swaps and Serology at Baseline, Day 21 and Day 40
This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.
Read the detailed description
This study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic infected persons.
In total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. There will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3).
The fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. For each timepoint the difference between the cohorts is investigated. This study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation.
Epidemiological exposure data and biological samples will be systematically collected. The present study is being conducted in line with World Health Organization recommendations to help understanding the epidemiology of SARS-Cov-2.
- Conditions
- COVID-19
- Being tested
- Blood sampling, Throat swab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood samples
Throat swabProcedure or surgery
Throat swab
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Workers working within a production area Receives: Procedure: Blood sampling; Procedure: Throat swab | |
| Group 2 | Workers working within a laboratory area Receives: Procedure: Blood sampling; Procedure: Throat swab | |
| Group 3 | Workers working within other areas Receives: Procedure: Blood sampling; Procedure: Throat swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responses to components of SARS-Cov-2
Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. Analysis of trends in CD4/CD8 concentrations over time and correlation with immunoglobulin G (IgG) Levels and new assay evaluation.
Measured: up to visit 3 (day 40)
Swabs for the presence of SARSCoV-2
Evaluation of Swab for the presence of SARS-CoV-2 by PCR and determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status.
Measured: up to visit 3 (day 40)
Secondary outcomes (1)
Difference between the study groups in anti-SARS-CoV 2 seropositivity status
Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status and analysis of trends in CD4/CD8 concentrations over time and correlation with IgG Levels as well as new assay evaluation.
Measured: up to visit 3 (day 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start22 Apr 2020
- Primary completion5 Nov 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe 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
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara von Ingersleben, Dr., Principal investigator, Miltenyi Biotec B.V. & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405466
- Sponsor's protocol ID
- M-2020-360
- Status last verified
- Jul 2020
- First submitted
- 19 May 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Epidemiological, Cohort Study to Assess the Feasibility of Screening Healthy Asymptomatic Workers for the Presence of SARS-CoV-2 by Pharyngeal Swaps and Serology at Baseline, Day 21 and Day 40
- ClinicalTrials.gov ID
- NCT04405466
- Acronym / sponsor ID
- M-2020-360
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 28 May 2020 (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.
This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.
Detailed description
This study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic infected persons.
In total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. There will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3).
The fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. For each timepoint the difference between the cohorts is investigated. This study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation.
Epidemiological exposure data and biological samples will be systematically collected. The present study is being conducted in line with World Health Organization recommendations to help understanding the epidemiology of SARS-Cov-2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Blood sampling, Procedure: Throat swabWorkers working within a production area |
| Group 2 | – | Procedure: Blood sampling, Procedure: Throat swabWorkers working within a laboratory area |
| Group 3 | – | Procedure: Blood sampling, Procedure: Throat swabWorkers working within other areas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Workers
Key inclusion criteria (5 listed)
- Healthy workers asymptomatic for SARS-CoV-2
- Ability to consent with the study and its procedures
- Age above 18 years old
- Full time employee on site at least 3 full working days a week
- Working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas.
Key exclusion criteria (14 listed)
- fever ≥38°C
- chills
- fatigue
- muscle ache (myalgia)
- sore throat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood samples | Procedure or surgery | Group 1, Group 2, Group 3 |
| Throat swabThroat swab | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Immune responses to components of SARS-Cov-2
Time frame: up to visit 3 (day 40)
Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. Analysis of trends in CD4/CD8 concentrations over time and correlation with immunoglobulin G (IgG) Levels and new assay evaluation.
Swabs for the presence of SARSCoV-2
Time frame: up to visit 3 (day 40)
Evaluation of Swab for the presence of SARS-CoV-2 by PCR and determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status.
1 secondary outcome
Difference between the study groups in anti-SARS-CoV 2 seropositivity status
Time frame: up to visit 3 (day 40)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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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.
Barbara von Ingersleben, Dr. principal investigator
Miltenyi Biotec B.V. & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Miltenyi Biomedicine GmbH at 1 site 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune responses to components of SARS-Cov-2 (time frame: up to visit 3 (day 40)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2022.