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

• Conditions: SARS-CoV-2

• Registration Number: NCT04391400
• Lead Sponsor: Invivoscribe, Inc.

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-18
• Study Start: 2020-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.