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

Study Overview
=================
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.

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

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Diagnostic Test: nasal pharyngeal (NP) swab samples
* Diagnostic Test: peripheral blood draw


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years |