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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

NCT04391400 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-05-18

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Invivoscribe, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordon Thornes · Laboratory for Personalized Molecular Medicine,

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391400 on ClinicalTrials.gov