HealthyC-VELVETNCT04954937
Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.
An observational study of Healthy, run by NHS Blood and Transplant at 1 site in United Kingdom.
Trial summary
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination. Read more about this study
- Who is it for?
- Ages 17 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2021to 20 Apr 2022
- 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 17 to 66 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Individuals who have had a previous SARS-CoV-2 infection
- Individuals who have previously donated COVID-19 convalescent plasma (CCP)
- Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine)
Who cannot join
- Not received a SARS-CoV-2 vaccine
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NHSBT - Birmingham Donation Centre
Birmingham
Richard Brain, Richard.brain@nhsbt.nhs.uk
About this study
Official title: Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.
Read the detailed description
This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff).
Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains.
The results of this study will:
- Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration.
- Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
- Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
- Assist in development of recording vaccination status on NHSBT databases of donors.
- Conditions
- Healthy
- Keywords
- Anti-SARS-CoV-2 antibodies, COVID-19, Convalescent plasma
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in antibody levels post-vaccination assessed via Euroimmun assay
Euroimmun assay
Measured: at least 28 days following vaccination
Increase in antibody levels post-vaccination assessed via Roche IgG assay
Roche IgG assay
Measured: at least 28 days following vaccination
Increase in antibody levels post-vaccination assessed vial live virus neutralization
Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants)
Measured: at least 28 days following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start20 Apr 2021
- Primary completion20 Oct 2021 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Blood and Transplant
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lise Jane Estcourt, NHS Blood and Transplant
- Investigators
- Lise Estcourt, MB BChir, DPhil, Principal investigator, NHS Blood and Transplant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954937
- Sponsor's protocol ID
- 21AS0001
- Acronym
- C-VELVET
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A- Individual participant data will note be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study
- ClinicalTrials.gov ID
- NCT04954937
- Acronym / sponsor ID
- C-VELVET / 21AS0001
- Conditions
- Healthy
- Keywords
- Anti-SARS-CoV-2 antibodies, COVID-19, Convalescent plasma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NHS Blood and TransplantOther government
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 8 Jul 2021 (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.
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.
Detailed description
This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff).
Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains.
The results of this study will:
- Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration.
- Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
- Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
- Assist in development of recording vaccination status on NHSBT databases of donors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Individuals who have had a previous SARS-CoV-2 infection
- Individuals who have previously donated COVID-19 convalescent plasma (CCP)
- Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine)
Key exclusion criteria (1 listed)
- Not received a SARS-CoV-2 vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in antibody levels post-vaccination assessed via Euroimmun assay
Time frame: at least 28 days following vaccination
Euroimmun assay
Increase in antibody levels post-vaccination assessed via Roche IgG assay
Time frame: at least 28 days following vaccination
Roche IgG assay
Increase in antibody levels post-vaccination assessed vial live virus neutralization
Time frame: at least 28 days following vaccination
Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No. N/A- Individual participant data will note be shared.
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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.
Lise Estcourt, MB BChir, DPhil principal investigator
NHS Blood and Transplant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by NHS Blood and Transplant at 1 site in United Kingdom.
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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lise Estcourt, MB BChir, DPhil (07823 351936, lise.estcourt@nhsbt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in antibody levels post-vaccination assessed via Euroimmun assay (time frame: at least 28 days following vaccination). The study lists 3 primary outcomes in all. 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 15 Jul 2021.