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

SARS-CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04391400
• Other study ID #: IVS-000-002
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: Invivoscribe, Inc.
• Contact: Ellen F Harris, BS
• Phone: 612.867.1904
• Email: eharris[@]invivoscribe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Invivoscribe, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Company Website