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NCT04604145 · ClinicalTrials.gov registry record · NA
Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR
A NA study of SARS-CoV Infection and Polymerase Chain Reaction, sponsored by David Grant U.S. Air Force Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04604145: Completed NA study of SARS-CoV Infection and Polymerase Chain Reaction, sponsored by David Grant U.S. Air Force Medical Center.
NCT04604145 is a NA study of SARS-CoV Infection and Polymerase Chain Reaction that has completed, run by David Grant U.S. Air Force Medical Center. The registered enrollment target is 60 participants, below the 3,504-participant average among 12 other SARS-CoV Infection trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04604145, a NA study of SARS-CoV Infection and Polymerase Chain Reaction, has completed, sponsored by David Grant U.S. Air Force Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. Investigators will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.
Primary Outcome
Percent positive agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen
Study Locations (1)
California
- David Grant U.S. Airforce Medical Center - Travis Air Force Base
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2021-08-18 |
| Phase | NA |
What the finished NCT04604145 record still lists
NCT04604145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,504-participant average among 12 other SARS-CoV Infection trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with SARS-CoV Infection appearing as the primary indexed condition, and to 1 intervention - of which SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen is the first listed.
NCT04604145 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04604145 about?
NCT04604145 is a clinical study titled "Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR". This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to ...
What is the current status of trial NCT04604145?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-02-03. Estimated completion is 2021-08-18.
What conditions does trial NCT04604145 study?
This clinical trial studies the following conditions: SARS-CoV Infection, Polymerase Chain Reaction, Laboratory Testing.
What interventions are being tested in trial NCT04604145?
The interventions under investigation include: SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04604145?
This trial is sponsored by David Grant U.S. Air Force Medical Center, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04604145 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04604145's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS-CoV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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