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NCT04345510 Clinical Trial

Testing for COVID-19 Infection in Asymptomatic Persons

COVID-19 Infection Clinical Trial

Official title:
Testing for COVID-19 Infection in Asymptomatic Persons

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04345510
Other study ID # COVID-19-1.0-DKFZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2020
Est. completion date September 30, 2021

Study information
Verified date March 2022
Source German Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: DKFZ employee Exclusion Criteria: Non DKFZ employee

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany German Cancer Research Center Heidelberg Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 infection 6 weeks
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