COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000843954.aspx

Prof Monica Slavin

monica.slavin@petermac.org

2020-08-26

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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

2

Peter MacCallum Cancer Centre

18

100

Australia

High risk patients

N/A

1914

ARM 1: Coprimary outcome 1Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19.COVID-19 confirmed by qPCR from respiratory swab .[3 months from baseline.];ARM 1: Coprimary outcome 2.incidence of any upper or lower community acquired respiratory viral infection (define as identification of respiratory viruses such as coronavirus other than SARS-CoV-2; influenza; parainfluenza; respiratory syncytial virus; rhinovirus; adenovirus; human metapneumovirus).assessed using local standard of care testing (e.g. respiratory swabs; saliva and/or blood)[3 months from baseline.]

Phase 3

[{"arm_notes": "", "treatment_id": 624, "treatment_name": "Ifn-a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]