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

NCT05107258 | Completed

• 1 other identifier: PTH-1233-01
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

SARS (Severe Acute Respiratory Syndrome); Covid19

Keywords

COVID-19; SARS COV-2

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The primary outcome of our study will be to determine the positive and negative comparator agreement (PPA and NPA), sensitivity and specificity of the Pine Trees Health COVID-19 diagnostic test.

  Two weeks

Secondary Outcomes (1)

• Secondary Outcome

  Two Weeks

Study Arms (1)

Subjects Symptomatic for COVID-19

Subjects must present with 1 or more of the following signs or symptoms: 1. Fever 2. Cough 3. Shortness of Breath 4. Difficulty Breathing 5. Muscle Pain 6. Headache 7. Sore Throat 8. Chills 9. New Loss of Taste or Smell 10. Congestion 11. Runny Nose 12. Diarrhea 13. Nausea or vomiting 2. Subjects must have experienced symptom onset within the previous 10 days

Diagnostic Test: The Pine Trees Health Test System

Interventions

The Pine Trees Health Test System DIAGNOSTIC_TEST

Consists of the Pine Trees Health Reader and the Pine Trees Health COVID-19 Test Kit, which contains the Pine Trees Health Cartridge, Pine Trees Health Sample Vial containing Sample Lysis Buffer and the Pine Trees Health Nasal Swab (anterior nares) for collection. The Test System is a point-of-care test used for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in nasal swabs taken from individuals who are suspected by a healthcare professional of having COVID-19. The COVID-19 test is a rapid molecular, in vitro diagnostic test using isothermal nucleic acid amplification technology and detection of the resulting amplicon using CRISPR-mediated collateral reporter unlocking.

Subjects Symptomatic for COVID-19

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals symptomatic of COVID-19

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.

Sponsors & Collaborators

• Pine Trees, Inc.: lead
• Eastside Research Associates: collaborator
• ICON plc: collaborator
• ASCLEPES Research Center: collaborator
• DuPage Medical Group: collaborator
• MRI Global: collaborator
• Piedmont Healthcare: collaborator

Study Sites (3)

ASCLEPES Research Center

Spring Hill, Florida, 34609, United States

Location

PMG Research of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anterior nares nasal swabs in VTM.

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Patrice Milos, PhD

  Pine Trees Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 4, 2021
• Study Start: August 17, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)