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COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04534725•Peter MacCallum Cancer Centre, Australia

View on ClinicalTrials.gov

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. 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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•ARM 1:
•1. Age equal to or greater than 18 years old
•2. Any haematological or solid tumour
•3. Signed written and verbal informed consent
•4. Willingness to inform the study nurse/co-ordinator of COVID-19 testing
•5. Willingness to perform a self-collect nose/throat swab
•ARM 2
•1. Age equal to or greater than 18 years old.
•2. Any haematological or solid tumour
•3. Signed written and verbal informed consent
+17 more criteria

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
•ARM 2
+21 more criteria

Locations (5)

Westmead Hospital

Westmead, New South Wales, Australia

St Vincent's Hospital

Fitzroy, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Key Dates

Start Date

December 17, 2020

Primary Completion Date

November 28, 2022

Completion Date

April 19, 2023

Last Updated

August 24, 2023

Enrollment

441

ACTUAL participants

Conditions

CancerCovid19Respiratory Viral Infection

Interventions

Interferon alfa

DRUG

Selinexor

DRUG

Lenzilumab

DRUG

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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RECRUITINGPHASE2

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

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GlandSalivary Gland Cancers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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