\r\n\tStatus: Currently Recruiting Documents in other languages Back to CONTROL-COVID home page
\r\n\tCOVID-19 is a new viral illness that emerged in December 2019. The virus that causes COVID-19 is called SARS-CoV-2. Infection with this virus can cause no symptoms at all, or it can cause illnesses ranging from very mild upper respiratory tract infections to life-threatening pneumonia. The virus is spreading rapidly, having infected over 6 million people worldwide between January 1 and June 3, 2020. We do not have very much experience with this virus and many things are still unknown about the virus itself, how it is transmitted, and how to prevent or treat the infection. Medical research is happening rapidly all over the world so we can better understand, prevent and treat this disease.
\r\n\r\n\tCOVID-19 is a respiratory illness with symptoms that may include fever, cough, shortness of breath, fatigue (feeling unusually tired), myalgia (muscle aches), arthralgia (pain in joints), loss of appetite, loss of smell and taste, changes in level of responsiveness, or changes in ability to perform activities of daily living (ADLs).
\r\n\r\n\tCanadians who are residents of long-term care homes (LTCHs) are a particularly frail older population, with an average age of over 85 years. We know that older people and those with pre-existing medical conditions are at much greater risk of COVID-19 infections that result in pneumonia, hospitalization, and respiratory failure requiring a ventilator.
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\r\n\tPreventative treatment of at-risk individuals with appropriate medications (chemoprophylaxis) is a proven control strategy for outbreaks of influenza in long term care homes (LTCHs). There is early evidence that medications used previously for other illnesses may be effective against COVID-19. The purpose of this study is to determine if favipirqvir is effective in preventing COVID-19 in residents and staff of LTCHs when COVID-19 outbreaks occur.
\r\n\tThis study is a cluster randomized, blinded, placebo-controlled trial of chemoprophylaxis to control outbreaks of COVID-19 in LCTHs.
\r\n\r\n\tThis means that eligible LTCH units with outbreaks of Covid-19 may be randomized to either the active drug (favipiravir) or a placebo (a pill that looks the same but does not contain any active medication). These medications are assigned randomly (by chance alone). No one except the person performing the randomization process will know which medication group each LTCH is assigned to. Participants and health care workers administering the medications will not know who is receiving active medication or placebo. All consenting residents and LTCH staff in the home will be taking the same drug at the same time.
\r\n\r\n\tLTCHs that are collaborating on this study, will provide the data necessary to determine if the facility can be included in the study. (link to inclusion criteria).
\r\n\r\n\tLTCHs which are eligible will be asked to report outbreaks to the study, in addition to their local public health unit. Public health units will have prior information regarding the study and will be able to direct any LTCH which has not previously been aware of the study when they report an outbreak.
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\r\n\tLTCHs which have already been pre-enrolled in the study will be asked to provide the study with resident, substitute decision maker (SDM), and staff contact information, excluding those who have asked not to be contacted. During the study period, the LTCH will share data about illness in residents who have given their consent to participate in the study. The study will work closely with each LTCH to identify the safest, best and least resource intensive process for conducting the study during an outbreak.
\r\n\tAll residents and staff members of eligible LTCH units experiencing an outbreak of COVID-19 will be asked to participate. Residents and staff will be asked to participate in the study whether or not they are eligible to receive study drug. Study personnel will contact residents (or SDMs) by telephone to obtain consent for participation in the study.
\r\n\r\n\tConsent includes permission for the study to:
\r\n\t 1. review resident medical records or staff health history and collect some data about underlying medical conditions before the outbreak, and any symptoms and illnesses for the duration of the study
\r\n\t 2. collect nasal swabs with any illness, and on day 0, 14 and 40 of the study
\r\n\t 3. dispense/administer the study drug (favipiravir or placebo) to the participant
\r\n\tThe study will be recruiting LTCHs from June 2020 to January 2021.
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\r\n\tResidents who have COVID-19 when the outbreak is declared (the start of the study) will receive treatment with study drug for 14 days. Residents and staff who are not infected will receive study drug for prevention for 25 days. All participating staff will be followed for 40 days; residents will be followed for 60 days.
\r\n\tThere are no physical risks to being part of the study except for those associated with study medication. The medication being used in this study is generally considered safe. However, like all medications, it may have side effects. Favipiravir is a medication that has been used in Japan to treat influenza for the last 7 years, but has not been used before in Canada. With favipiravir, there is a possibility of risks that we do not yet know about. More information about favipiravir can be found in the consent forms and in medication information forms on this website. Potential risks will be discussed in detail when consent for participation in the study is being obtained. Everyone considering participation will have an opportunity to discuss this and any other questions they may have at that time. Study personnel will be available to address any questions or concerns at any time during the study.
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\r\n\tHealth Canada has approved the use of favipiravir for this study.
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\r\n\tThe study has been approved by the Research Ethics Board of Sinai Health System.
\r\n\tYou can call the Toronto study office at 416-586-4800 ext.2763 and leave a message or email us at CONTROL.COVID@sinaihealth.ca. A member of the study staff will then arrange to talk to you as soon as possible about the study so you can decide whether or not you wish to participate. If you are a participant and your enquiry is URGENT, please contact the study through locating at Sinai Health (416-586-5133).
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\r\n\tContact Information
\r\n\tDr. Allison McGeer, (Principal Investigator) 416-586-3123 Allison.McGeer@sinaihealth.ca
\r\n\r\n\tStudy Office 416-586-4800 ext.2763 CONTROL.COVID@sinaihealth.ca
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\r\n| \r\n\t\t\t\tInvestigators | \r\n\t\t\t\r\n\t\t\t\tAffiliation | \r\n\t\t
|---|---|
| \r\n\t\t\t\tDr. Allison McGeer, Principal Investigator | \r\n\t\t\t\r\n\t\t\t\tSinai Health System | \r\n\t\t
| \r\n\t\t\t\tDr. Eric Coomes | \r\n\t\t\t\r\n\t\t\t\tUniversity of Toronto | \r\n\t\t
| \r\n\t\t\t\tDr. Adrienne Chan | \r\n\t\t\t\r\n\t\t\t\tSunnybrook Health Sciences | \r\n\t\t
| \r\n\t\t\t\tDr. Rhonda Collins | \r\n\t\t\t\r\n\t\t\t\tRevera Living | \r\n\t\t
| \r\n\t\t\t\tMr. Bruno daCosta | \r\n\t\t\t\r\n\t\t\t\tApplied Health Research Centre, Unity Health | \r\n\t\t
| \r\n\t\t\t\tDr. Nick Daneman | \r\n\t\t\t\r\n\t\t\t\tSunnybrook Health Sciences | \r\n\t\t
| \r\n\t\t\t\tDr. Carol Epstein | \r\n\t\t\t\r\n\t\t\t\tFujifilm Pharmaceuticals USA | \r\n\t\t
| \r\n\t\t\t\tDr. Frederick Hayden | \r\n\t\t\t\r\n\t\t\t\tUniversity of Virginia | \r\n\t\t
| \r\n\t\t\t\tMs. Alainna Jamal | \r\n\t\t\t\r\n\t\t\t\tSinai Health System | \r\n\t\t
| \r\n\t\t\t\tDr. Peter Juni | \r\n\t\t\t\r\n\t\t\t\tApplied Health Research Centre, Unity Health | \r\n\t\t
| \r\n\t\t\t\tDr. David Juurlink | \r\n\t\t\t\r\n\t\t\t\tSunnybrook Health Sciences | \r\n\t\t
| \r\n\t\t\t\tDr. Christopher Kandel | \r\n\t\t\t\r\n\t\t\t\tSinai Health System | \r\n\t\t
| \r\n\t\t\t\tDr. Kevin Katz | \r\n\t\t\t\r\n\t\t\t\tNorth York General Hospital | \r\n\t\t
| \r\n\t\t\t\tDr. Tony Mazzulli | \r\n\t\t\t\r\n\t\t\t\tSinai Health System | \r\n\t\t
| \r\n\t\t\t\tDr. Mohammad Mozafrihasjin | \r\n\t\t\t\r\n\t\t\t\tSinai Health System | \r\n\t\t
| \r\n\t\t\t\tDr. Samira Mubareka | \r\n\t\t\t\r\n\t\t\t\tSunnybrook Health Sciences | \r\n\t\t
| \r\n\t\t\t\tDr. Elizabeth Rea | \r\n\t\t\t\r\n\t\t\t\tUniversity of Toronto, Dalla Lana School of Public Health | \r\n\t\t
| \r\n\t\t\t\tDr. Andrew Simor | \r\n\t\t\t\r\n\t\t\t\tSunnybrook Health Sciences | \r\n\t\t
| \r\n\t\t\t\tDr. Darrell Tan | \r\n\t\t\t\r\n\t\t\t\tUnity Health | \r\n\t\t
| \r\n\t\t\t\tMr. Kevin Thorpe | \r\n\t\t\t\r\n\t\t\t\tUniversity of Toronto | \r\n\t\t
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\r\n\r\n\tFavipiravir has been provided by Appili Therapeutics.
\r\n\r\n\tStudy is sponsored by Appili Therapeutics.
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