Frequently Asked Questions
Why is this research being done?
There are no drugs of proven value against COVID-19 although there are several which may turn out to be helpful (or possibly harmful) when added to the usual standard of care. This study aims to find out whether any of these additional treatments are of any help.
What is the purpose of this study?
This study aims to compare several different treatments that may be useful for patients with COVID-19. Although these treatments show promise, nobody knows if any of them will turn out to be more effective in helping patients recover than the usual standard of care at your hospital (which all patients will receive).
Who is doing this study?
The study is being led by Dr. Edward Mills and Kristian Thorlund from McMaster University and Cytel Inc., and locally organized by Dr. Gilmur Reis from Pontifical Catholic University of Minas Gerais in Brazil.
Who is being included in the study?
Adults aged between 18-80 years who have a confirmed SARS-CoV-2 infection, with test results within past 72 hours and/or adults who are at increased risk of developing severe COVID-19 disease.
What happens next if I agree to be included in this this study?
If you decide to join, you will be asked to sign the consent form. Next, brief details identifying you and answering a few questions about your health and medical conditions will be entered into a computer. The computer will then allocate you at random (like rolling a dice) to one of the possible treatment options. In all cases this will include the usual standard of care for your hospital. It may also include an additional treatment, which might be given by mouth, injection or inhalation. Neither you nor your doctors can choose which of these options you will be allocated. If your condition is severe or should deteriorate, then your doctors may choose to enter you into a second phase in which the computer will allocate you at random again to one of the further possible treatment options (in addition to your previous study treatment and always including usual standard of care for your hospital).
What are the possible benefits of this study?
We do not know if any of the treatments being tested will have additional benefits. Your study treatment may or may not help you personally, but this study should help future patients.
What are the possible risks of being in this study?
Apart from the known side effects of these treatments (which may include tummy upset, ‘flu-like symptoms, and blood test abnormalities), there is the unlikely possibility of a severe reaction to a study drug. Women who are pregnant may be included, however, the effect of some of the treatments on unborn babies is uncertain - although all the treatments have previously been used in pregnancy for other medical conditions without safety concerns being raised. If you do receive treatment and are not already pregnant, as a precaution, we advise that you should not get pregnant within 3 months of the completion of the trial treatment(s). Please ask your hospital doctor if you would like more information. Once you have been included in the study, you and your doctors will know which treatment the computer has allocated for you. Your doctors will be aware of whether there are any particular side effects that they should look out for.
Can I stop the treatment or my participation early?
If you or your doctor want to stop the study treatment before the course has been completed, then you are free to do so. If you decide that you do not wish any more information to be collected about you, you are free to say so (although de-identified information that has been collected up to that point will continue to be analysed by the research team).
If I have any questions or problems, who should I contact?
If you have any questions please speak to your hospital medical team. Further information about the study will also be available on this website.
What information do you hold about me and how do you keep it private?
All information about you and your health will be kept private. The only people allowed to look at the information will be the doctors who are running the study, the staff at the study coordinating centre, and the regulatory authorities who check that the study is being carried out correctly. A privacy notice is on the study website.
Are there any financial costs or payments?
All trial treatments will be free. Neither you nor your medical staff will be paid for your participation in this study.
Who is funding this study?
Different organizations support different interventions being evaluated in this trial. For example; the evaluations of Hydroxychloriquine and Lopinavir/ritonivir were supported by the Bill and Melinda Gates Foundation. The evaluations of Metformin, Ivermectin, and Fluvoxamine have been supported by Fast Grants. Overall trial infrastructure is supported by the Rainwater Foundation. New interventions may recieve funding from other organizations in the future. The funders have no role in the conduct, interpretation, or dissemination of the study findings.
How long do you plan to keep my data?
The Sponsor will keep identifiable information about you for up to one year after the study has finished.