Chronic Complications of COVID-19

Study: Chronic Complications of COVID-19

REB # 102920

You are invited to take part in a study of long-term health outcomes among individuals with suspected or confirmed COVID-19, and those at risk of being infected. Please read the following information carefully to determine whether you would like to participate. 

Why is this study being done?

Some people who fall ill with COVID-19 report ongoing, relapsing, or evolving symptoms beyond the expected time for recovery. Long-term complications have been described for a number of infectious diseases, although it is not clear why this happens, and why it affects some people more than others. The goal of this study is to understand and track the types of long-term symptoms that people experience as a result of COVID-19. In a follow-up study, those who wish and who meet geographic and medical criteria will be offered the opportunity to participate in 2 follow-up studies. One of these studies involves having blood and urine samples tested for antibodies to the coronavirus that causes COVID-19 and for altered immune, viral and metabolic functions. The other is a study of the long-term trajectory of COVID-19 recovery in which those wishing to participate would be contacted again in a year to assess symptoms. In the long-term, similarities and differences we find between conditions may help to define diagnostic criteria and inform the development of new therapies to address these long-term complications. 

What does this study involve?

This study is open to all people who wish to complete the survey. This survey will ask you about yourself, your medical history, your exposure to and experiences with COVID-19 and it's effect on your life. Those completing the survey will be eligible to participate in one or both of two follow-up studies, one involving a follow up in approximately one year and the other looking at markers in blood and urine.  

The online questionnaire consists of 87 questions and should take approximately one hour to complete. 

You may complete the questionnaire in one sitting or save it and resume it later. 

Informed consent:

Before you can decide whether or not to participate, you must understand the purpose of the study, how it may affect you, any risks to you and what is expected of you.  This process is called informed consent. Important considerations are:

• Your participation is entirely voluntary. You may choose to participate or not and you can change your mind at any point before submitting the survey.
• You may choose not to answer any questions you do not wish to answer.  
• Your response will be confidential and the results of the survey will be presented so that no specific individuals can be identified. Collected information will be de-identified and aggregated to ensure the protection of personal information, your name will not be downloaded when analysis of data is performed.
• Your healthcare provider will not know if you participated in this survey. The results of this survey will not be linked to your medical records. The quality of your health care will not be affected by whether or not you participate. 
• Information on who has and has not participated will not be communicated to anyone in a workplace, even if you heard about this in the workplace.
• No one will know that you have participated in this survey unless you choose to tell them. 

Who is eligible to participate?

Anyone who meets the following criteria is invited to participate in the online questionnaire:

• Suspected/confirmed COVID-19 with ongoing symptoms, OR
• Suspected/confirmed COVID-19 that resolved, OR
• Frontline worker at risk of COVID-19 but without known infection (for example, medical personnel)
• Fluent in English or French
• Has access to a device with an internet connection, to complete online survey
• Can give consent

Potential risks 

Your contribution to this study is important because it will help the research team to understand the experiences of people with presumed and confirmed COVID-19. We do not anticipate risks to you or to others as a result of participation, but for some participants, recalling details of an illness may be disturbing. If you find any question to be distressing in any way, you can choose not to answer it. If completing the questionnaire causes you to become distressed please seek support either through a friend/family member, counselor, support group, medical professional or (if severe) a crisis support network (for example, this website can help you connect with an appropriate resource in your area). Please note that these surveys will not be processed quickly and will be de-identified for analysis so if you are at risk of immediate self-harm or harming others, it is important to reach out to these resources. 

Potential benefits 

There are no direct, immediate benefits to participating in this study. This is an opportunity for you to share your experience with COVID-19. You may benefit indirectly in the future if the results of the investigation are used to improve the outcomes of those with longstanding symptoms. 

Alternatives to participation 

If you would like to contribute to research on COVID-19 but do not wish to participate in this study, you can monitor COVID-19 support groups for other opportunities to support research. 

1. The Body Politic Slack - https://www.wearebodypolitic.com/covid19. This forum includes survivors from around the world, but has a channel specifically devoted to Canadians. 

2. The COVID Longhaulers Canada Facebook group - https://www.facebook.com/groups/950023472135178/. 

3. The COVID Longhaulers Support Group Canada Facebook group - https://www.facebook.com/groups/920314451799658/. 

Questions

This research has been reviewed and approved by the Mount Allison University Research Ethics Board. If you have any questions or concerns about this study, you may contact Dr. Hamilton, Chair of the Mount Allison University Research Ethics Board, by phone (506-364-2618) or by e-mail at reb@mta.ca.