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

Status: Unknown

Conditions: SARS-CoV-2

Treatments: Diagnostic Test: peripheral blood draw; Diagnostic Test: nasal pharyngeal (NP) swab samples

Study type: Observational

Funder types: Industry

Identifiers

NCT04391400

IVS-000-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.