Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Relate… (NCT04442048) | Clinical Trial Compass
CompletedPhase 3
Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
Canada195 participantsStarted 2020-10-01
Plain-language summary
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
* Patients must have one or more of the following risk factors \[CDC 2019\] 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 (e.g. heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
* lung (e.g. chronic obstructive pulmonary disease (COPD including emphysema and chronic bronchitis), moderate to severe asthma, idiopathic pulmonary fibrosis and cystic fibrosis)
* liver cirrhosis
* serious kidney disease requiring dialysis
* Receiving systemic therapy (such as cytotoxic chemotherapy, immunotherapy or targeted agents excluding single-agent hormonal therapy)
* Body Mass Index \> 40
* Living in a nursing home or long term care facility
* Patient must have a life expectancy of \>6 months as assessed by the investigator
* Patient must have an ECOG Performance Status ≤ 2
* Patient has adequate organ function appropriate for the therapy the patient is planned to receive in the opinion of the investigator and based on lo…