CONCOR-DONOR

SickKids logo

What is CONCOR-DONOR?

CONCOR-DONOR is a longitudinal cohort study of adults who have recovered from COVID-19 and have volunteered to donate convalescent plasma.

The outbreak caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has risen to the level of a global pandemic, affecting more than 4 million individuals worldwide in 187 countries, with a case fatality rate of 6.9% (as of May 11, 2020). 

There are currently no proven treatments for coronavirus disease (COVID-19); however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. The unknown role for convalescent plasma in treating COVID-19 necessitates further study. 

As trials are underway to determine the efficacy of using convalescent plasma to treat COVID-19, we will use this unique opportunity to conduct a national longitudinal cohort study of ~2400 persons >17 years of age recovered from COVID-19 who volunteer to donate their convalescent plasma.

If you are interested in participating in CONCOR-DONOR, please fill out the interest form by clicking the link below

Study goals

Study details

Our research team invites you to take part in an observational study as you were infected with the novel coronavirus and developed coronavirus disease, called COVID-19. This research study will study immunity during the recovery stage in those with COVID-19 and up to one year after infection. Participating in any research study is voluntary: there is absolutely no requirement to participate.

This observational study will determine the protective effects of the immune system, which forms antibodies, small proteins that circulate in the blood that can bind to the virus, after having COVID-19. These antibodies are detected early on after infection. There are a number of types of antibodies which vary in amount and duration. We do not know a lot about the protective antibodies and need to understand for how long a person may be protected with antibodies.

When people get sick with COVID-19, their body makes antibodies or immune protein which are special parts of the blood to help fight off the infection. These antibodies stay in the blood after a person has recovered from COVID-19 infection. People who have had COVID-19 can then donate their blood that contains these antibodies located in the plasma portion of the blood.

There is a lot of information that we do not know such as the type of antibodies in convalescent plasma and how long these antibodies last in the blood. We also do not know if the antibodies vary by age, sex or presence of other conditions such as high blood pressure, heart disease, etc. We will also determine if genetic factors lead to differences in antibodies levels or COVID-19 infection. With this observational study, we hope to answer these questions.

All individuals that have tested positive for, and recovered from, COVID-19 are eligible to participate in the study or if there was a household member that has tested positive and experienced COVID-19 symptoms.  We are recruiting both males and females to the study over age 17 years from across Canada. We anticipate recruiting thousands of people across the country.

Participation in the study will be for one year. In the study, we ask you to complete some questionnaires online and provide blood samples at enrollment, 6 months and 12 months from enrollment.

Questionnaires

Participants will be asked to complete online questionnaires prior to the donation of biological samples. The questionnaires will ask questions regarding contact information, demographics, geographic region, severity of symptoms, time of infection, and health questions. 

Blood collection

After completion of the questionnaires, we will work with you to plan a visit to LifeLabs, or an equivalent organization for blood collection. We will collect up to 3 tablespoons worth of blood, which will be sent to SickKids. We will then process the specimens at SickKids and label it with a study ID. This means that your specimens will be deidentified. Follow-up blood draws will occur at a 6- and 12- month follow-up.

This national study will include participants in most provinces. We will ask for some personal health identified information to reach out to collect health data. We may contact hospitals or clinic to find out information about COVID-19. We will  also link to available health data both provincially and nationally to understand long-term follow-up and risk of heart and lung disease. Linking to your health data will give us information about the healthcare resources you use outside of your local hospital so we can get a better understanding of your overall health.

Participation in the study carries some risk with the potential of bruising, and tenderness at the site of the blood draw. There is also loss of time from participating in the study and travel to get the blood drawn. With storing of data and biological specimens for future study, there is the potential for loss of confidentiality or privacy. We have procedures and security in place to ensure your privacy.

There is no direct benefit to you for joining the study. You will be contributing to greater knowledge about COVID-19 and information that will inform treatments for COVID-19 and future emerging infections.  

You can choose to leave the study at any time. You will need to notify the study team at concor-donor@sickkids.ca.  

Participation in the study will not cost you anything.

We will use the samples to test for specific types of antibodies and also genes associated with COVID-19 and antibody response. We will conduct genetic sequencing in conjunction with the Canadian genetic sequencing platform (CGEn) driven COVID-19 Host Genomic Sequencing Initiative. Biobanking involves the collection of your biological samples to store for further research use. An important goal of the CONCOR-Donor study is to create a repository, for future COVID-19 research with data and biological samples. Without biological samples, we would not be able to generate information for treatment such as vaccines or use of convalescent plasma.

Your de-identified samples will only be shared with other researchers once they have gone through a scientific review process with CONCOR-Donor study investigators and also ethics review committee at their respective institution. Researchers from other universities, the government, and drug- or health-related companies can apply to use the samples. An industry partner is an organization that may be a pharmaceutical company that wants to make a new drug or test a currently approved drug for another disease or population. It may also be a biotechnology company that develops new ways to treat or diagnose disease. If you consent for industry partner sharing, SickKids may receive money in exchange for your samples and study information. Any funds we receive will be used support our ongoing research on COVID-19 and health related complication.

We will respect your privacy at all times. No information about you will be given to anyone or be published without your permission, unless the law requires us to do this. All information shared will not use identifiable information.

A description of this observational study will be available on http://www.clinicaltrials.gov

Only individuals who tested positive for COVID-19 are eligible for the study. If an individual received a positive antibody test after their infection with COVID-19 they are also eligible for the study. Additionally, if you experienced symptoms at the same time as a household contact who received a positive test result, you are eligible for the study.

No, you will not receive information about your COVID-19 immune status. General study results will be shared on the study website and through journal publications and academic conferences, but they will not be specific or identifiable by you or other participants.

If you decide to participate, you will have the ability to contact the research team to set up an appointment to have a virtual discussion about the study. You will also be sent a copy of the consent to review before the discussion. This will give you an opportunity to ask any questions you may have and decide if you wish to sign the consent to participate in the study.

If you are interested in participating after having the consent discussion with the team, you will be asked to sign the consent electronically. If at any time you further questions, please email the team at concor-donor@sickkids.ca.

When you are prepared to sign the consent electronically, you will be asked to initial if you consent to:

  • long-term storage of your samples and data
  • sharing your samples and data with other researchers in the future individually.
  • sharing your samples with drug- or health-related companies
  • release of your health-related information from hospital or clinical records and data linkage with provincial and national health databases

You will receive a copy of the consent by email and be provided with an email (concor-donor@sickkids.ca) and phone number to contact for more information about the study. The consent will be password protected to ensure security. Be sure to ask the study team by email or phone at 416-813-7654 ext. 304819 about anything you do not understand—the team is here to help guide you!

All rights reserved 2020 © The Hospital for Sick Children (SickKids)