IC8

IC8 Details
Status: Closed
Activation Date: 2020JUN25
Closing Date: 2021MAY14
Phase: III

Description: 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

Eligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2

Objective: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned.

Participation: Limited to invited centres

Lay Description: The purpose of the trial is to find out if immunization with IMM-101 will prevent or reduce severe respiratory and COVID-19 infections in cancer patients. IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer. It works by activating the parts of your immune system involved with protecting against viral and bacterial 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.

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Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
SYMPTOM CONTROL	IC8	195	0	0	0

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
SYMPTOM CONTROL	IC8	195	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
SYMPTOM CONTROL	IC8	195	195	0	0	0	195	195	0	0