Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05107258 |
| Other study ID # |
PTH-1233-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 17, 2021 |
| Est. completion date |
September 16, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Pine Trees, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 capital of China's Hubei province, and has since spread globally,
resulting in the ongoing 2019-20 (and now 2021) coronavirus pandemic. The first confirmed
case of what was then an unknown coronavirus was traced back to November 2019 in Hubei.
Common symptoms include fever, dry cough, fatigue, sputum production, loss of smell, and
shortness of breath. While the majority of cases result in mild symptoms, some cases progress
to viral pneumonia and multi-organ failure. Emergency symptoms include difficulty breathing,
persistent chest pain or pressure, confusion, difficulty waking, and bluish face or lips. The
time from exposure to onset of symptoms is typically around five days but may range from two
to fourteen days.
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.
