A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care

Completed

Conditions studied: SARS (Severe Acute Respiratory Syndrome), Covid19

In brief

The scope of this study is to validate the Pine Trees Health COVID-19 Molecular Test with unique clinical specimens from across two (2) geographically diverse point-of-care testing sites in the United States. The results will be analyzed and compared against results from the CDC 2019- Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The primary objective is to generate clinical performance data for the Pine Trees Health COVID19 molecular diagnostic test in the point-of-care setting.

Key facts

Study ID

NCT05107258

Run by

Pine Trees, Inc.

People needed

195

Starts

2021-08-17

Expected to finish

2021-09-16

Last updated by the study team

2021-11-04

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must present with 1 or more signs or symptoms of COVID-19 infection*.
• Subjects must have experienced symptom onset within the previous 10 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 ≥ 6 years of age. Subjects 6 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.

You may not qualify if…

• Individual 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 <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.
• Symptoms may appear 2-10 days after exposure and may include one or more of the following: 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.

Where it is running

• ASCLEPES Research Center — Spring Hill, Florida, United States
• PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
• Eastside Research Associates — Redmond, Washington, United States

Full record on ClinicalTrials.gov

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