AzTrials
AzTrials

CancerPhase 3C-SMARTNCT04534725

COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;

A Phase 3 study testing Interferon alfa, Selinexor and Lenzilumab in people with Cancer and Covid19, run by Peter MacCallum Cancer Centre, Australia at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Covid19, Respiratory Viral Infection
What is being tested?
Interferon alfa, Selinexor and Lenzilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
5 sitesAustralia
Study dates
17 Dec 2020to 19 Apr 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ARM 1:
  • Age equal to or greater than 18 years old
  • Any haematological or solid tumour
  • Signed written and verbal informed consent
  • Willingness to inform the study nurse/co-ordinator of COVID-19 testing
  • Willingness to perform a self-collect nose/throat swab
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  • ARM 2
  • Age equal to or greater than 18 years old.
  • Any haematological or solid tumour
  • Signed written and verbal informed consent
  • 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.
  • Willingness to inform the study nurse/co-ordinator of COVID-19 testing
  • Willingness to perform a self-collect nose/throat swab
  • ARM 3 1. Age equal to or greater than 18 years of age. 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. Laboratory confirmation of SARS-CoV-2 by PCR as per local laboratory assays 6. Hospitalised 7. Symptoms of COVID-19 such as:
  • Fever equal to or greater than 38 degrees Celsius OR
  • Tachypnoea respiratory rate equal to or greater than 20 breaths/min OR
  • Pulse Oxygen saturation (SpO2) equal to or less than 94% 8. Concurrent standard of care antimicrobials, antivirals are allowed. 9. Female and male patients of child bearing potential will use highly effective contraception. In female child bearing potential participants a negative urine pregnancy test will be required.
  • ARM 4
  • Age equal to or greater than 18 years of age.
  • Any haematological or solid tumour
  • 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
  • Signed written and verbal informed consent by participant or proxy capable of giving consent
  • Laboratory virological confirmation of SARS-CoV-2 by PCR as per local laboratory assays and COVID-19 diagnosis prior to randomisation
  • Hospitalised but has not required mechanical ventilation
  • Pneumonia diagnosed by chest x-ray or computed tomography (CT) revealing infiltrates consistent with pneumonia and SpO2 equal to or less than 94% on room air or requires low-flow oxygen supplementation or requires high-flow oxygen supplementation or non-invasive positive pressure ventilation (NIPPV).
  • Has not participated in other clinical trials for COVID-19 using an immunomodulating monoclonal antibody or kinase inhibitor. Note that participants on dexamethasone, corticosteroids, remdesivir, convalescent plasma and/or hydroxychloroquine with or without azithromycin are not excluded from the study. Agents that have received emergency use authorization and/or are considered by the study site to be standard treatment at the institution for COVID-19 are permitted provided the agent is not an immunomodulating monoclonal antibody or kinase inhibitor. Participation in clinical trials with remdesivir or convalescent plasma is permitted provided that all other eligibility criteria are met.
  • Females of childbearing potential must have a negative serum or urine pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 5 months following their last dose of study drug.

Who cannot join

  • ARM 1
  • Previous diagnosis of COVID-19 (microbiologically proven, either symptomatic or asymptomatic)
  • 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.
  • 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
  • Pregnant or breast-feeding women, or women who wish to become pregnant during the course of the study
  • Participant unable to return for regular follow-up
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  • Life expectancy of less than 4 months
  • Participant already included in another intervention study on the prevention of COVID-19
  • Currently unwell with influenza-like symptoms - if participant is found to be COVID-19 negative and becomes asymptomatic, they can be reconsidered for participation
  • ARM 2
  • Previous diagnosis of COVID-19 (microbiologically proven, either symptomatic or asymptomatic)
  • 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
  • Pregnant or breast-feeding women, or women who wish to become pregnant during the course of the study
  • Patient unable to return for follow-up
  • Life expectancy of less than 1 month
  • Patient already included in another intervention study on the prevention of COVID-19
  • Currently unwell with influenza-like symptoms
  • ARM 3
  • Unable to take oral medication
  • Any known allergic reactions to selinexor or concomitant medication-related contra-indications to selinexor.
  • Severe critical COVID-19 infection defined as:
  • Requiring invasive or non-invasive mechanical ventilation, ECMO
  • Anticipated unlikely to survive within 48 hours
  • In the opinion of the investigator and primary oncologist, participation in the study would not be in the best interests of the participant
  • Severe renal impairment defined as creatinine clearance (CrCL) < 20ml/min as calculated using the Cockcroft Gault formula
  • Severe hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x upper limit of normal (ULN)
  • ARM 4
  • 1. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 2. History of pulmonary alveolar proteinosis (PAP). 3. Women of childbearing potential who are pregnant or breastfeeding. 4. Known hypersensitivity to lenzilumab or any of its components. 5 .Use of any FDA-approved anti-IL-6 therapy (eg. tocilizumab, sarilumab, siltukimab), anti-IL-1 therapy (eg. anakinra, canakinumab) or kinase inhibitor (eg.baracitinib, ibrutinib, acalabrutinib) therapy to treat COVID-19 within 8 weeks prior to randomization. Any live vaccine within 8 weeks prior to randomisation. Note that subjects receiving other FDA-approved immunomodulators to treat underlying autoimmune disorders such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, asthma, chronic obstructive pulmonary disease, atopic dermatitis, multiple sclerosis, etc. would not be excluded. Participants on corticosteroids or dexamethasone are not excluded from the study. Note: Participants on convalescent plasma, remdesivir and/or hydroxychloroquine with or without azithromycin are not excluded from the study.
  • 6. Use of GM-CSF agents (e.g., sargramostim) within 8 weeks prior to randomisation.
  • 7. Expected survival < 24h in the opinion of the investigator. 8. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the subject at unacceptably high risk from the study.
  • 9. Participation in another interventional study of COVID-19

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3052

  • Austin Health

    Melbourne, Victoria, 3084

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; C-SMART Study.

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.

ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts.

Read more

ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus.

ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection.

ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection.

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 of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

Being tested
Interferon alfa, Selinexor, Lenzilumab
Keywords
COVID-19, cancer
Medical subject headings
Neoplasms, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon alfaDrug

    intranasal spray

  • SelinexorDrug

    oral tablet

  • LenzilumabDrug

    intravenous infusion

Study groups in NCT04534725
Study groupRoleWhat they receive
prophylaxisExperimentalThis 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. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intranasal 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.
Receives: Drug: Interferon alfa
Post-Exposure ProphylaxisExperimentalThis study arm (arm 2) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intranasal spray for 7 days (at a higher dose than arm 1) while the other group will receive a daily placebo intranasal spray for 7 days Participants will be followed for 28 days for incidence of COVID-19 and other respiratory infections.
Receives: Drug: Interferon alfa
Moderate COVID-19 infectionExperimentalThis study arm (arm 3) is evaluating the effect of Selinexor on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive oral Selinexor 3 times a week for 2 weeks while the other group will receive oral placebo 3 times a week for 2 weeks Participants will be followed for 60 days to assess effectiveness and safety.
Receives: Drug: Selinexor
Severe COVID-19 infectionExperimentalThis study arm (arm 4) is evaluating the effect of Lenzilumab on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive intravenous Lenzilumab over 24 hours while the other group will receive placebo intravenously over 24 hours. Participants will be followed for 60 days to assess effectiveness and safety.
Receives: Drug: Lenzilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence 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)

    Incidence 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)

    Measured: 3 months from baseline.

  2. incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing

    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)

    Measured: 3 months from baseline.

  3. incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .

    incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .

    Measured: 28 days from baseline

  4. incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing

    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)

    Measured: 28 days from baseline

  5. incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records

    composite outcome: incidence of death and/or need for invasive or non-invasive ventilation.

    assessed using medical records

    Measured: 60 days from baseline

  6. time to clinical improvement or discharge from hospital assessed using medical records

    time to clinical improvement (defined as a two point reduction in clinical progress ordinal scale) or discharge from hospital, whichever occurs first.

    assessed using medical records

    Measured: 28 days from baseline

Secondary outcomes (46)

  1. ARM 1: Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. Assessed using patient symptom Diary PRO tool

    ARM 1, secondary endpoint 1 Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. (composite either COVID-19 or other respiratory viral infection).

    assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

    Measured: 120 days from baseline

  2. ARM 1: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records

    ARM 1, secondary endpoint 2 Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records

    Measured: 120 days from baseline

  3. ARM 1: Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records

    ARM 1, secondary endpoint 3. Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records

    Measured: 120 days from baseline

  4. ARM 1: Illness severity in case of confirmed COVID-19 diagnosed during the study period using WHO clinical progression scale

    ARM 1, secondary endpoint 4 Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression scale ranging from 0 (uninfected) to 10 (death)

    Measured: 120 days from baseline

  5. ARM 1: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records

    ARM 1, secondary endpoint 5 Incidence of unplanned all-cause hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records

    Measured: 120 days from baseline

  6. ARM 1: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

    ARM 1, secondary endpoint 6 Incidence of unplanned infection-related hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records

    Measured: 120 days from baseline

  7. ARM 1: Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR

    ARM 1, secondary endpoint 7 Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR

    Measured: 120 days from baseline

  8. ARM 1: Incidence of death from any cause during the study period. assessed using patient medical records

    ARM 1, secondary endpoint 8 Incidence of death from any cause during the study period. assessed using patient medical records

    Measured: 120 days from baseline

  9. ARM 1: Incidence of testing for COVID-19 during the study period. assessed using medical records

    ARM 1, secondary endpoint 9 Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records

    Measured: 120 days from baseline

  10. ARM 2 Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period. assessed with PRO and medical records.

    ARM 2: secondary outcome 1. Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period (days).

    assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

    Measured: 28 days from baseline

  11. ARM 2: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records

    ARM 2: secondary outcome 2. Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records

    Measured: 28 days from baseline

  12. ARM 2: Illness severity in case of confirmed COVID-19 diagnosed during the study period. assessed using WHO clinical progression scale.

    ARM 2: secondary outcome 3. Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)

    Measured: 28 days from baseline

  13. ARM 2: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.

    ARM 2: secondary outcome 4. Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.

    Measured: 28 days from baseline

  14. ARM 2: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

    ARM 2: secondary outcome 5 Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

    Measured: 28 days from baseline

  15. ARM 2: Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.

    ARM 2: secondary outcome 6 Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.

    Measured: 28 days from baseline

  16. ARM 2: Incidence of testing for COVID-19 during the study period assessed using medical records

    ARM 2: secondary outcome 7. Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records

    Measured: 28 days from baseline

  17. ARM 3: Time to clinical improvement assessed using medical records.

    ARM 3: secondary outcome 1 Time to clinical improvement defined as

    1. Resolution of fever - oral temperature < 38oC for 24 hours without antipyretics AND
    2. Respiratory rate < 20 breaths/minute OR
    3. Oxygen saturation > 94% on room air OR
    4. Hospital discharge assessed using medical records

    Measured: 60 days from baseline

  18. ARM 3: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale

    ARM 3: secondary outcome 2. Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)

    Measured: 60 days from baseline

  19. ARM 3: change to clinical condition assessed with Karnofsky Performance score

    ARM 3: secondary outcome 3 change to clinical condition assessed with Karnofsky Performance score

    Measured: 60 days from baseline

  20. ARM 3: Time to progression to severe COVID-19, defined by WHO ordinal scale

    ARM 3: secondary outcome 4. Time to progression to severe COVID-19, defined by WHO ordinal scale

    Measured: 60 days from baseline

  21. ARM 3: Time to all-cause mortality

    ARM 3: secondary outcome 5 Time to all-cause mortality

    Measured: 60 days from baseline

  22. ARM 3:Duration of hospitalisation assessed using medical records

    ARM 3: secondary outcome 6. Duration of hospitalisation. assessed using medical records

    Measured: at discharge or day 60 whichever is sooner

  23. ARM 3: Duration of COVID-19 symptoms assessed using patient reported symptom diary.

    ARM 3: secondary outcome 7 Duration of COVID-19 symptoms assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

    Measured: 60 days from baseline

  24. ARM 3: Duration of oxygen supplementation (days). assessed using medical records.

    ARM 3: secondary outcome 8. Duration of oxygen supplementation (days). assessed using medical records.

    Measured: 60 days from baseline

  25. ARM 3: change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)

    ARM 3: secondary outcome 9 change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)

    Measured: 60 days from baseline

  26. ARM 3: Safety and tolerability of selinexor using relevant medical records

    ARM 3: secondary outcome 10. Safety and tolerability of selinexor defined as listing and documentation of frequency and severity of adverse effects. Outcome assessed using any/all of medical records, patient reported, vital signs, ECG, imaging, other investigative procedure as per standard local practice.

    Measured: 60 days from baseline

  27. ARM 3: incidence of changes in blood results relevant to clinical improvement assessed using medical records

    ARM 3: secondary outcome 11. composite outcome: incidence of changes in blood results relevant to clinical improvement.

    1. Changes in C-reactive protein (CRP)
    2. Changes in ferritin level
    3. Changes in lactate dehydrogenase (LDH) level

    Measured: 60 days from baseline

  28. ARM 4: Incidence of all cause death by day 28 and 60

    ARM 4: secondary outcome 1 Incidence of all cause death by day 28 and 60 assessed using medical records

    Measured: day 28 from baseline and day 60 from baseline

  29. ARM 4: Time to all-cause mortality

    ARM 4: secondary outcome 2 Time to all-cause mortality assessed using medical records

    Measured: any time up to 60 days from baseline

  30. ARM 4: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale

    ARM 4: secondary outcome 3 - composite outcome:

    Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)

    1. Proportion who have recovered (defined as 0-4)
    2. Proportion who had 1 point improvement
    3. Proportion who had 2 point improvement

    Measured: any time up to 60 days from baseline

  31. ARM 4: Incidence of ARDS assessed using medical records

    ARM 4: secondary outcome 4 Incidence of ARDS. assessed using medical records

    Measured: any time up to 60 days from baseline

  32. ARM 4: incidence of HLH. assessed using medical records

    ARM 4: secondary outcome 5 incidence of HLH. assessed using medical records

    Measured: any time up to 60 days from baseline

  33. ARM 4: Duration of hospitalisation. assessed using hospital medical records.

    ARM 4: secondary outcome 6 Duration of hospitalisation. assessed using hospital medical records.

    Measured: at discharge or by day 60 whichever is sooner

  34. ARM 4: Proportion discharged from hospital. assessed using medical records

    ARM 4: secondary outcome 7 Proportion discharged from hospital. assessed using medical records

    Measured: at discharge

  35. ARM 4: Incidence of mechanical ventilation up to day 28. assessed using medical records

    ARM 4: secondary outcome 8. Incidence of mechanical ventilation up to day 28. assessed using medical records

    Measured: any time up day 28 from baseline

  36. ARM 4: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records

    ARM 4: secondary outcome 9 composite outcome: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records

    Measured: any time up to 60 days from baseline

  37. ARM 4: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.

    ARM 4: secondary outcome 10. composite outcome: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.

    Measured: any time up to 60 days from baseline

  38. ARM 4: Incidence and duration of ICU admission. assessed using medical records

    ARM 4: secondary outcome 11 composite outcome: Incidence and duration of ICU admission. assessed using medical records

    Measured: at discharge or by day 60 from baseline.

  39. ARM 4: incidence and duration of supplemental oxygen use. assessed using medical records

    ARM 4: secondary outcome 12 composite outcome: incidence and duration of supplemental oxygen use. assessed using medical records

    Measured: any time up to 60 days from baseline

  40. ARM 4: Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours.

    ARM 4: secondary outcome 13. Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours.

    assessed using medical records

    Measured: any time up to 60 days from baseline

  41. ARM 4: incidence of non-invasive ventilation. assessed using medical records

    ARM 4: secondary outcome 14 incidence of non-invasive ventilation. assessed using medical records

    Measured: any time up to 60 days from baseline

  42. ARM 4: number of participants alive and off oxygen at day 60. assessed using medical records.

    ARM 4: secondary outcome 15. composite outcome: number of participants alive and off oxygen at day 60. assessed using medical records.

    Measured: any time up to 60 days from baseline

  43. ARM 4: proportion of participants who had improved oxygenation for >48 hours. assessed using medical records

    ARM 4: secondary outcome 16 proportion of participants who had improved oxygenation for >48 hours. assessed using medical records

    Measured: any time up to 28 days from baseline

  44. ARM 4: Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records

    ARM 4: secondary outcome 17 Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records

    Measured: any time up to day 28 from baseline.

  45. ARM 4: incidence of SAEs based on NCI CTCAE v5 assessed using medical records

    ARM 4: secondary outcome 18 incidence of SAEs based on NCI CTCAE v5 assessed using medical records

    Measured: any time up to 28 days from baseline.

  46. ARM 4: change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.

    ARM 4: secondary outcome 19 change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.

    Measured: any time up to day 60 from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start17 Dec 2020
  3. Primary completion28 Nov 2022
  4. Study completion19 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
the study uses a SMART design. (sequential multiple arm randomised trial) meaning that participants can enter into the study and progress through the subsequent arms if they meet the additional eligibility criteria (for instance, pre-covid \> post exposure \> develop moderate infection \> infection becomes severe) it is important to note that participants can enter into the study at any point and do not have to transition into the other arms
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534725
Sponsor's protocol ID
Peter Mac ID 20/135
Acronym
C-SMART
Status last verified
Aug 2023
First submitted
30 Aug 2020
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yong MK, Thursky K, Crane M, Spelman T, Mahar RK, Simpson JA, Scott AM, Harrison SJ, Szer J, Pellegrini M, Lingaratnam S, Pang KC, Tennakoon S, Sim BZ, Blyth E, Gan HK, Quach H, McIntosh MP, Page H, Woolstencroft R, Slavin M. Interferon-alpha Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Infect Dis. 2026 Feb 25;82(2):e208-e216. doi: 10.1093/cid/ciaf409.

    PubMed 40874769

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon alfa, Selinexor and Lenzilumab in people with Cancer and Covid19, run by Peter MacCallum Cancer Centre, Australia at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence 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) (time frame: 3 months from baseline.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04534725, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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