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IMM-101 Immunization for COVID-19 in Cancer Patients (COV-IMMUNO Trial)
COV-IMMUNO Trial Summary
This trial will test whether IMM-101 can reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
COV-IMMUNO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOV-IMMUNO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 110 Patients • NCT01303172COV-IMMUNO Trial Design
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Who is running the clinical trial?
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- I can and will fill out health questionnaires in English or French.My organs are functioning well enough for the treatment, according to my doctor.I can attend all treatments and follow-ups for the study.I have had a bone marrow transplant in the past.I am currently receiving or about to receive treatment for cancer.I am at high risk for severe COVID-19 due to my age, health conditions, or living situation.I agree to get pneumococcal and flu shots as per Canadian guidelines.I agree to use effective birth control during and for 3 months after treatment.I am 18 years old or older.I have never tested positive for COVID-19.I have bladder cancer and am being treated with BCG.You have HIV, Hepatitis B, or Hepatitis C.You have had an allergic reaction to a mycobacterial product, like the BCG vaccine.I haven't had flu-like symptoms in the last 14 days.I have been treated with IMM-101 before.I have had leukemia before or have it now.I have a severe autoimmune disease or condition requiring steroids or immunosuppressants.I can take care of myself and perform daily activities.
- Group 1: IMM-101
- Group 2: Observation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What does the FDA's opinion of IMM-101?
"IMM-101 has been studied in Phase 3 trials, which indicates that there is some data supporting its efficacy and multiple rounds of data supporting its safety. Our team at Power estimates that IMM-101 is safe to use, with a score of 3 on a scale from 1 to 3."
Does this experiment have a large geographic scope?
"So far, 8 patients have been enrolled in this study at locations such as CIUSSS de l'Estrie - Centre hospitalier in Sherbrooke, The Research Institute of the McGill University in Montreal, and Odette Cancer Centre in Toronto."
What are some other studies that have used IMM-101 as a treatment?
"IMM-101 was first studied in 2020 at the Ottawa Hospital Research Institute. Since then, there have been a total of 90 completed clinical trials. Currently, there is 1 live trial, with many of these trials taking place in Sherbrooke, Quebec."
Are people with this condition able to sign up for the trial at this time?
"Unfortunately, this particular clinical trial is not recruiting patients at this time. It was originally posted on 2020-06-25, with the most recent update taking place on 2022-09-12. For individuals interested in other trials, there are 2323 clinical trials actively recruiting patients with malignancies and 1 trial for IMM-101 that is also recruiting patients."
How many people fit the bill for this clinical research?
"Unfortunately, this particular clinical trial is not seeking patients at the moment. It was initially posted on 2020-06-25 and updated for the last time on 2022-09-12. However, there are 2323 trials for patients with malignancies and 1 study for IMM-101 that are actively recruiting participants."
Is this research the inaugural effort of its type?
"right now, there is a single ongoing trial for IMM-101 in 6 locations and 1 nation. The first such study was in 2020. Conducted by Immodulon Therapeutics Ltd, the Phase 3 clinical trial had 195 patients and completed drug approval in 2020. As of now, 90 similar studies have been undertaken."
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