Infections

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

COVID-19

Communicable Diseases

Virus Diseases

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Interferons

Interferon-alpha

Lenzilumab

Antiviral Agents

Immunologic Factors

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.

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.

This 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.

This 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.

This 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.

Interferon alfa

Selinexor

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.

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

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.

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 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)

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 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)

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

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

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.

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

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

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)

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

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

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

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

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.

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

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)

ARM 2: secondary outcome 4. Incidence of unplanned all-cause 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

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

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

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

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)

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

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

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

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

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.

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

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

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.

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

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

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

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

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

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

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

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

ARM 4: secondary outcome 8. Incidence of mechanical ventilation up to day 28. 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

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

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

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

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

ARM 4: secondary outcome 14 incidence of non-invasive ventilation. 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.

ARM 4: secondary outcome 16 proportion of participants who had improved oxygenation for \>48 hours. 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

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

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

Spots Global Cancer Trial Database for lenzilumab

Every month we try and update this database with for lenzilumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lenzilumab

Every month we try and update this database with for lenzilumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lenzilumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.