Official Title
The Use of Peripheral Blood Specimens From Patients Suspected of Having SARS-CoV-2 Infections in Research Studies Intended to Support the Development of COVID-19 Detection Methods, Treatments, and/or Vaccines
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.

Unknown status
SARS-CoV-2

Diagnostic Test: nasal 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 Test: peripheral 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.

Eligibility Criteria

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 exclusion criteria related to age, gender, race, ethnicity, geography,
and/or other medical conditions.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Contacts

Ellen F Harris, BS
612.867.1904
eharris@invivoscribe.com

Jason Gerhold
858.224.6674
jgerhold@invivoscribe.com

Jordon Thornes, Principal Investigator
Laboratory for Personalized Molecular Medicine,

Invivoscribe, Inc.
NCT Number
MeSH Terms
COVID-19