Covid19CONCOR-DonorNCT04555109
Convalescent Plasma for COVID-19 Research Donor Study
An observational study of Covid19, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, natural history study of plasma donors recovered from COVID-19. CONCOR-Donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Covid19
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2020to 31 Oct 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 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All that recovered from COVID-19 above age 17, that have tested positive or a household contact that tested positive regardless of eligibility to donate plasma for the trials.
Who may be able to join
- Recovered from COVID-19 infection
- Have a positive PCR or serology or a positive household contact
- Signed informed consent form
- Provide blood sample
- Ability to complete a questionnaire
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma for COVID-19 Research (CONCOR) Donor Study
Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, natural history study of plasma donors recovered from COVID-19. CONCOR-Donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. We will also study long-term outcomes from COVID-19 infection. Results from the study will help define therapeutic strategies for COVID-19.
Read the detailed description
The outbreak caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) led to the global pandemic. There are currently no proven treatments for coronavirus disease (COVID-19), however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. Convalescent plasma was successfully used for other infections, in small numbers, but there is limited evidence for the efficacy of administering specific, neutralizing antibodies by transfusion of convalescent plasma. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.
As trials are underway to determine efficacy of using convalescent plasma, we will use this unique opportunity to conduct a national longitudinal cohort study of 1000 persons recovered from COVID-19 and volunteer to donate convalescent plasma. Our aims are to:1) determine if the variability of titers of viral neutralizing antibody and ELISA antibody are associated with clinical and demographic factors; 2) determine duration of protective immunity in recovered persons over 1 year and if modified by clinical and demographic factors; 3) determine genetic risk predictors of the antibody response, and 4) create a biorepository available to researchers from across Canada. Based on the World Health Organization (WHO) Coordinated Global Research Map, this project addresses the priority of the natural history of COVID-19 and clinical characterization of antibody response in the convalescent phase and beyond.
- Conditions
- Covid19
- Keywords
- Covid19, Convalescent plasma, Seroconversion, Immunity, National, Biorepository, Observational Study
- Medical subject headings
- COVID-19, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Convalescents | The cohort will include up to 1000 persons recovered from COVID-19, ages 17 - 65, that will provide a written consent form to participate in the study, complete questionnaires and provide a blood sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence and duration of protective immunity
Determine if the titers of SARS-CoV-2-specific neutralizing antibody and serum ELISA antibodies, are correlated with clinical and demographic factors such as age, sex, comorbidities, geographic region, and severity of prior COVID-19 symptoms, during the convalescent phase.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start30 Jun 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rulan Parekh, The Hospital for Sick Children
- Investigators
- Rulan Parekh, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555109
- Sponsor's protocol ID
- 1000070462
- Acronym
- CONCOR-Donor
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma for COVID-19 Research (CONCOR) Donor Study
- ClinicalTrials.gov ID
- NCT04555109
- Acronym / sponsor ID
- CONCOR-Donor / 1000070462
- Conditions
- Covid19
- Keywords
- Covid19, Convalescent plasma, Seroconversion, Immunity, National, Biorepository, Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 18 Sep 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.
Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, natural history study of plasma donors recovered from COVID-19. CONCOR-Donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. We will also study long-term outcomes from COVID-19 infection. Results from the study will help define therapeutic strategies for COVID-19.
Detailed description
The outbreak caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) led to the global pandemic. There are currently no proven treatments for coronavirus disease (COVID-19), however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. Convalescent plasma was successfully used for other infections, in small numbers, but there is limited evidence for the efficacy of administering specific, neutralizing antibodies by transfusion of convalescent plasma. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.
As trials are underway to determine efficacy of using convalescent plasma, we will use this unique opportunity to conduct a national longitudinal cohort study of 1000 persons recovered from COVID-19 and volunteer to donate convalescent plasma. Our aims are to:1) determine if the variability of titers of viral neutralizing antibody and ELISA antibody are associated with clinical and demographic factors; 2) determine duration of protective immunity in recovered persons over 1 year and if modified by clinical and demographic factors; 3) determine genetic risk predictors of the antibody response, and 4) create a biorepository available to researchers from across Canada. Based on the World Health Organization (WHO) Coordinated Global Research Map, this project addresses the priority of the natural history of COVID-19 and clinical characterization of antibody response in the convalescent phase and beyond.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Convalescents | – | –The cohort will include up to 1000 persons recovered from COVID-19, ages 17 - 65, that will provide a written consent form to participate in the study, complete questionnaires and provide a blood sample. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All that recovered from COVID-19 above age 17, that have tested positive or a household contact that tested positive regardless of eligibility to donate plasma for the trials.
Key inclusion criteria (5 listed)
- Recovered from COVID-19 infection
- Have a positive PCR or serology or a positive household contact
- Signed informed consent form
- Provide blood sample
- Ability to complete a questionnaire
Key exclusion criteria (1 listed)
- None
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
Seroprevalence and duration of protective immunity
Time frame: 12 months
Determine if the titers of SARS-CoV-2-specific neutralizing antibody and serum ELISA antibodies, are correlated with clinical and demographic factors such as age, sex, comorbidities, geographic region, and severity of prior COVID-19 symptoms, during the convalescent phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Rulan Parekh, MD principal investigator
The Hospital for Sick Children
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 Covid19, run by The Hospital for Sick Children at 1 site in Canada.
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 5 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 25 Oct 2022. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence and duration of protective immunity (time frame: 12 months). 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 25 Oct 2022.