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
1 other identifier
observational
500
0 countries
N/A
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).
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jun 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMay 18, 2020
May 1, 2020
1.1 years
May 14, 2020
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Biospecimen
The donated specimens will be: * 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.
Study Officials
- PRINCIPAL INVESTIGATOR
Jordon Thornes
Laboratory for Personalized Molecular Medicine,
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 18, 2020
Study Start
June 1, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
May 18, 2020
Record last verified: 2020-05