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

May 14, 2020 updated by: Invivoscribe, Inc.
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an open study that will accept donations from any patients who both are being tested by LabPMM, LLC for COVID-19 and who sign the related ICF.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invivoscribe, Inc.

Investigators

  • Principal Investigator: Jordon Thornes, Laboratory for Personalized Molecular Medicine,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (ACTUAL)

May 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVS-000-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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