A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests
Completed · Not applicable
Conditions studied: SARS CoV-2
In brief
The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.
Key facts
- Study ID
- NCT04568356
- Run by
- E25Bio, Inc.
- People needed
- 200
- Starts
- 2020-04-24
- Expected to finish
- 2020-09-24
- Last updated by the study team
- 2020-10-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of verbal informed consent form
- Subject is suspected case of COVID-19 by clinical criteria a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
- No other etiology that fully explains the clinical presentation
- With or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
- Subject is an appropriate candidate for Nasopharyngeal sample collection
- Subject is willing to provide nasopharyngeal swab and saliva samples
You may not qualify if…
- Individuals who present to ER with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence
Where it is running
- JFK Medical Center — Miami, Florida, United States
- Kendall Regional — Miami, Florida, United States
- Aventura Hospital and Medical Center — Miami, Florida, United States
Full record on ClinicalTrials.gov
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