NCT04345510

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

April 12, 2020

Last Update Submit

March 28, 2022

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

  • COVID-19 infection

    6 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DKFZ employees

You may qualify if:

  • DKFZ employee

You may not qualify if:

  • Non DKFZ employee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 14, 2020

Study Start

April 20, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)