C-SMART.COVID-19 Prevention and Treatment in Cancer. Arm 1 : Prevention in patients not infected with COVID-19.

Phase 3

Completed

• Conditions: COVID-19; Cancer; Infection - Other infectious diseases; Cancer - Any cancer; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000843954
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-26
• Study Completion: 2023-04-01
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified