Status:
COMPLETED
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
Lead Sponsor:
Proof Diagnostics
Collaborating Sponsors:
ICON Clinical Research
MRI Global
Conditions:
COVID-19
Asymptomatic COVID-19
Eligibility:
All Genders
2+ years
Brief Summary
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular compar...
Detailed Description
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December 2019 in Wuhan, the cap...
Eligibility Criteria
Inclusion
- For Symptomatic Subjects:
- Subjects must present with 1 or more of the following signs or symptoms:
- Fever Cough Shortness of Breath Difficulty Breathing Muscle Pain Headache Sore Throat Chills New Loss of Taste or Smell Congestion Runny Nose Diarrhea Nausea or vomiting
- Subjects must have experienced symptom onset within the previous 5 days.
- Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent.
- Subject is ≥ 2 years of age. Subjects ages 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
- For Asymptomatic Subjects:
- Asymptomatic subjects must have been exposed to known SARS-CoV-2 positive or suspected SARS-CoV-2 symptomatic individuals within the previous 5 days.
- Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent.
- Subject is ≥ 2 years of age. Subjects ages 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
- Note that subjects in recognized vulnerable populations, such as pregnant women and the cognitively impaired, will not be specifically targeted for recruitment, however individual subjects within vulnerable populations may be enrolled. The Human Subject's Protections procedures employed in this protocol are sufficient to protect the rights and welfare of any subject within an eligible vulnerable population and no additional measures are necessary.
Exclusion
- The subject is not able to tolerate sample collection.
- The subject has been positive for SARS-CoV-2 previously.
- The subject underwent a nasal wash/aspirate as part of standard of care within 24 hours prior to the study visit.
- The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- The subject has previously participated in this research study.
Key Trial Info
Start Date :
February 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT05331976
Start Date
February 9 2022
End Date
March 21 2022
Last Update
April 25 2022
Active Locations (3)
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1
Asclepes Research Center
Spring Hill, Florida, United States, 34609
2
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States, 28625
3
Eastside Research Associates
Redmond, Washington, United States, 98052