NCT04391400

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Invivoscribe, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-05-18
• Last updated: 2020-05-18

Regulatory

• FDA-regulated device study