SARS-CoV-2
Conditions
Brief summary
Invivoscribe, Inc. and its wholly owned subsidiary LabPMM, LLC are collecting peripheral blood specimens from patients with suspected SARS-CoV-2 viral infections. These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC. Specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel SARS-CoV-2 detection methods and COVID- 19 treatments and/or prevention methods (e.g. drug or vaccine development).
Detailed description
This research protocol describes the collection and analysis of peripheral blood samples to: * Identify nucleic acid sequences that may be used aide in the development of SARSCoV- 2 detection methods. * Identify antibodies that may be used aide in the development of SARS-CoV-2 detection methods. * Identify antigens that may be used aide in the development of SARS-CoV-2 detection methods. -Identify nucleic acid sequences that may be used aide in the development of COVID- 19 treatments and/or vaccines. * Identify antibodies that may be used aide in the development of COVID-19 treatments and/or vaccines. * Identify antigens that may be used aide in the development of COVID-19 treatments and/or vaccines.
Interventions
DIAGNOSTIC_TESTnasal pharyngeal (NP) swab samples
These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC.
DIAGNOSTIC_TESTperipheral blood draw
From patients suspected of SARS-CoV-2 viral infections. * At least 2mL to 5mL of peripheral blood. * Collected in EDTA tubes. * Shipped to ambient LabPMM, LLC within 2 days. * Specimen Collections: * Collected at the same time as the NP specimen sent for COVID-19 testing. * Collected two to three weeks post the original patient's COVID-19 testing.
Sponsors
Invivoscribe, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* From patients suspected of SARS-CoV-2 viral infections. * From patients who have had COVID-19 testing prescribed by their treating physicians. * From patients whose COVID-19 test specimen was sent to LabPMM, LLC for testing
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines | 2 years | This research protocol describes the collection and analysis of peripheral blood samples to: * Identify nucleic acid sequences that may be used aide in the development of SARSCoV- 2 detection methods. * Identify antibodies that may be used aide in the development of SARS-CoV-2 detection methods. * Identify antigens that may be used aide in the development of SARS-CoV-2 detection methods. * Identify nucleic acid sequences that may be used aide in the development of COVID- 19 treatments and/or vaccines. * Identify antibodies that may be used aide in the development of COVID-19 treatments and/or vaccines. * Identify antigens that may be used aide in the development of COVID-19 treatments and/or vaccines. |
Contacts
Primary ContactEllen F Harris, BS
Backup ContactJason Gerhold
Outcome results
None listed