None listed
Conditions
Brief summary
A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 1) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, have a negative COVID-19 test and without known positive contact with COVID-19 Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intransal spray for 3 months while the other group will receive a daily placebo intranasal spray for 3 months. Participants will be followed during the 3-month treatment for incidence of COVID-19 and other respiratory infections. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.
Interventions
ARM 1 - Prophylaxis
Drug: IFN-a
Dose: 40,000 IU/Daily
Duration: 3 months
Mode: Intranasal spray (self administered)
Adherence: drug return logs, patient reported.
Description of study design:
This SMART design specifies that participants entering the trial who have had no known COVID-19 exposure are initially randomised to either low-dose intranasal IFN-a or placebo as pre-exposure prophylaxis against developing COVID-19. Any participants who have a known COVID-19 exposure are randomised to hi
ARM 1 - Prophylaxis Drug: IFN-a Dose: 40,000 IU/Daily Duration: 3 months Mode: Intranasal spray (self administered) Adherence: drug return logs, patient reported. Description of study design: This SMART design specifies that participants entering the trial who have had no known COVID-19 exposure are initially randomised to either low-dose intranasal IFN-a or placebo as pre-exposure prophylaxis against developing COVID-19. Any participants who have a known COVID-19 exposure are randomised to high-dose IFN-a or placebo as a post-exposure prophylaxis against developing COVID-19. If, at any stage after enrolling, a participant develops ‘moderate’ COVID-19, then they are then randomised to either selinexor or placebo, and if at any stage after enrolling the participant develops ‘severe’ COVID-19 they are then randomised to either lenzilumab or placebo. Importantly, participants enrolling into the trial can directly enter any of the four interventions if they meet the appropriate entry criteria.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ARM 1: 1. Age equal to or greater than 18 years old 2. Any haematological or solid tumour 3. Current or within the last 12 months received cancer related treatment such as chemotherapy, radiotherapy or targeted small molecule, cellular therapy or immune-modulating therapy 4. Signed written and verbal informed consent 5. Willingness to inform the study nurse/co-ordinator of COVID-19 testing 6. Willingness to perform a self-collect nose/throat swab
Exclusion criteria
ARM 1 1. Previous diagnosis of COVID-19 (microbiologically proven, either symptomatic or asymptomatic) 2. Have been exposed to a known COVID-19 case within the last 72 hours, defined by the current Department of Health and Human services such as household contact, 15 minutes of face to face exposure, 2 hours in close space. 3. Any contra-indication to intra-nasal IFN-a such as severe nasal bleeding requiring intervention, nasal malignancy, nasal deformity, radiotherapy to the nasopharynx and/or oropharynx 4. Pregnant or breast-feeding women, or women who wish to become pregnant during the course of the study 5. Participant unable to return for regular follow-up 6. Life expectancy of less than 4 months 7. Participant already included in another intervention study on the prevention of COVID-19 8. Currently unwell with influenza-like symptoms – if participant is found to be COVID-19 negative and becomes asymptomatic, they can be reconsidered for participation
Outcome results
None listed