CONCOR-DONOR

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.

Yes, you are eligible to participate in the study even if you were vaccinated for COVID-19. In fact, we encourage you to get vaccinated when you are offered.

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.

We will collect up to 3 tablespoons of blood only and not plasma. The bloodwork procedure should not take more than 15-30 minutes.

No, you do not need to fast to provide a blood sample for the study.

No, antibiotics, antivirals, painkillers or any other medications do not affect blood collection.

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.

Study recruitment is now closed. Our research team will now continue to complete follow-up of all the enrolled participants.