A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care
NCT ID: NCT05107258
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
195 participants
OBSERVATIONAL
2021-08-17
2021-09-16
Brief Summary
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Detailed Description
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As of December 4th, 2020, more than 67.3 million cases have been reported across 185 countries and territories, resulting in more than 1.54 million deaths. On December 2nd, 2020 the Pfizer/BioNTech vaccine was approved in the United Kingdom, followed by approval in the United States (under Emergency Use Authorization \[EUA\]) on December 11th , 2020. Numerous antiviral and anti-inflammatory treatments have been proposed for COVID-19. Today, management involves the treatment of symptoms, supportive care, isolation, and experimental measures. The WHO has published several testing protocols for the disease \[7\]. The standard method of testing is real-time reverse transcription polymerase chain reaction (rRT-PCR). The test is typically done on respiratory samples obtained by a nasopharyngeal swab and more recently mid-turbinate and anterior nares nasal swab, and sputum sample or saliva may also be used. Results are generally available within 12-18 hours but can take upwards of two - four days depending on the testing needs of the community. Blood tests can be used, but these require two blood samples taken two weeks apart, and the results have little immediate value. Blood tests can be used to detect antibodies to the virus. The FDA in the United States authorized under EUA the first antigen point-of-care test on 21 March 2020 for use at the end of that month and more recently Lucira has received EUA authorization for at-home-testing.
The FDA has continued to request novel, molecular diagnostic tests which can be offered as point-of-care tests with the potential for future at-home use with a prescription. Pine Trees Health believes our Pine Trees Health Test System offers an important improvement to the global testing challenge, providing a state-of-the-art CRISPR-based test for detecting SARS-CoV-2 with sensitivity comparable to the gold standard RT-qPCR (Limit of Detection of 300 copies/mL, sensitivity \>95%, specificity \>99%). The Pine Trees Health Test System thus offers a low-cost and scalable alternative which will be utilized in this clinical study protocol and enable our EUA submission based on the data generated.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
The Pine Trees Health Test System
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.
Interventions
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The Pine Trees Health Test System
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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have experienced symptom onset within the previous 10 days.
3. 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.
4. Subject is ≥ 6 years of age. Subjects 6 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
Exclusion Criteria
2. The subject has been positive for SARS-CoV-2 previously.
3. The subject underwent a nasal wash/aspirate as part of standard of care \<24 hours prior to the study visit.
4. 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.
5. 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.
6 Years
ALL
No
Sponsors
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Eastside Research Associates
UNKNOWN
ICON plc
INDUSTRY
ASCLEPES Research Center
UNKNOWN
DuPage Medical Group
OTHER
MRI Global
INDUSTRY
Piedmont Healthcare
OTHER
Pine Trees, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patrice Milos, PhD
Role: STUDY_DIRECTOR
Pine Trees Health
Locations
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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
Countries
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Other Identifiers
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PTH-1233-01
Identifier Type: -
Identifier Source: org_study_id