SARS-CoV-2NCT04391400
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
An observational study of SARS-CoV-2, run by Invivoscribe, Inc..
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- nasal pharyngeal (NP) swab samples and peripheral blood draw
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria related to age, gender, race, ethnicity, geography, and/or other medical conditions.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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.
- Conditions
- SARS-CoV-2
- Being tested
- nasal pharyngeal (NP) swab samples, peripheral blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal pharyngeal (NP) swab samplesDiagnostic test
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 drawDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invivoscribe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordon Thornes, Principal investigator, Laboratory for Personalized Molecular Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391400
- Sponsor's protocol ID
- IVS-000-002
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04391400
- Acronym / sponsor ID
- IVS-000-002
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Invivoscribe, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria related to age, gender, race, ethnicity, geography, and/or other medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal pharyngeal (NP) swab samplesThese 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 drawFrom 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordon Thornes principal investigator
Laboratory for Personalized Molecular Medicine,
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Invivoscribe, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen F Harris, BS (612.867.1904, eharris@invivoscribe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.