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

Invivoscribe, Inc.500 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

SARS-CoV-2

Interventions

peripheral blood drawDIAGNOSTIC_TEST

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

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines

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.

Time frame: 2 years