Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (COV-IMMUNO)
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|ClinicalTrials.gov Identifier: NCT04442048|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Covid-19||Biological: IMM-101 Other: Observation||Phase 3|
There is currently no vaccination available for COVID-19. However, there are vaccinations for the seasonal flu and pneumonia.
IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections. Laboratory tests show that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, so that if you are exposed to these types of infections your body may be able fight off the infection better. That could help prevent severe symptoms from respiratory and COVID-19 related infections. It has been studied in over 300 cancer patients who have also been receiving other cancer treatments, including chemotherapy and radiation, and seems promising, but it is not clear if it can offer better results than not having the immunization at all.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COV-IMMUNO: A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
The treatment regimen with IMM-101 will be one 1.0 mg/mL (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg/mL (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg/mL (= 0.05 mL) on Day 45 (+/-14 days)
Three doses of IMM-101 on days 0, 14, and 45.
|Active Comparator: Observation||
No active treatment. Observation only
- The rate of "flu-like illness" which includes: [ Time Frame: 1 year ]
- WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND
- Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
- The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented [ Time Frame: 1 year ]
- The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death [ Time Frame: 1 year ]
- The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times). [ Time Frame: 1 year ]
- The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months [ Time Frame: 3, 6, and 12 months ]
- The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L [ Time Frame: 1 year ]
- Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death [ Time Frame: 1 year ]
- Overall survival (OS), as time from enrollment to death from any cause [ Time Frame: 1 year ]
- Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101 [ Time Frame: 1 year ]
- Incidence and frequency of local injection site reactions subsequent to IMM-101 administration [ Time Frame: 1 year ]
- Incidence and duration of ICU admission related to documented COVID-19 infection [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442048
|Contact: Chris O'Callaghanemail@example.com|
|Study Chair:||Rebecca A Auer||Ottawa Hospital Research Institute|