Clinical trial NCT04391400: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Lead sponsor: Invivoscribe, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory for Personalized Molecular Medicine,
name: Jordon Thornes
role: PRINCIPAL_INVESTIGATOR
References: