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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00021220 |
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Date of registration:
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01/04/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the performance of novel rapid diagnostics for COVID-19 at point-of-care
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Scientific title:
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Evaluation of the performance of novel rapid diagnostics for COVID-19 at point-of-care - Novel rapid diagnostics for COVID-19 |
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Date of first enrolment:
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17/04/2020 |
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Target sample size:
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5000 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00021220 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Claudia
Denkinger |
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Address:
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Im Neuenheimer Feld 324
69120
Heidelberg
Germany |
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Telephone:
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+49 6221 56-36637 |
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Email:
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claudia.denkinger@uni-heidelberg.de |
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Affiliation:
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Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin |
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Name:
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Claudia
Denkinger |
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Address:
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Im Neuenheimer Feld 324
69120
Heidelberg
Germany |
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Telephone:
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+49 6221 56-36637 |
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Email:
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claudia.denkinger@uni-heidelberg.de |
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Affiliation:
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Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin |
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Key inclusion & exclusion criteria
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Inclusion criteria: Suspected COVID-19 cases; preselected by local Public Health department
Exclusion criteria: o Hemodynamic instability as determined by the treating physician
o Patient unable to cooperate with respiratory sample collection
o Patient unable to give informed consent
o Recent history of excessive nose bleeds
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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U07.1
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COVID-19, virus identified
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COVID-19
U07.1
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Intervention(s)
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Group 1: Potential study participants will be invited through phone calls by the Rhine-Neckar Health Department if they are a suspect of a COVID-19 infection and will be tested in the drive-in. In the drive-in, potential study participants are asked whether they would be willing to participate voluntarily in the validation of a new antigen test in addition to the standard PCR test and if this is the case, a further swab is taken from the study participants after signing the consent form. This swab is not used for clinical diagnosis and is only used for validation of the antigen test.
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Primary Outcome(s)
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Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard
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Secondary Outcome(s)
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1. Time to proficiency, implementation issues, design related issues at POC
2. Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard
3. Survival analysis for the outcome of death within 2-3 months by COVID and Antigen test status
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Source(s) of Monetary Support
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Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin
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Ethics review
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Status: Approved
Approval date: 24/03/2020
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
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