Created at Source Raw Value Validated value
June 25, 2024, noon usa

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 4. 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. 5. willingness to inform the study nurse/co-ordinator of covid-19 testing 6. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.

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 4. 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. 5. willingness to inform the study nurse/co-ordinator of covid-19 testing 6. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: 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 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.

inclusion criteria: 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 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.

Aug. 13, 2021, 4:30 p.m. usa

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 4. 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. 5. willingness to inform the study nurse/co-ordinator of covid-19 testing 6. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.

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 4. 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. 5. willingness to inform the study nurse/co-ordinator of covid-19 testing 6. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.

Oct. 26, 2020, 11:31 p.m. usa

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 arm 2 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. 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. 6. willingness to inform the study nurse/co-ordinator of covid-19 testing 7. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.

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 arm 2 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. 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. 6. willingness to inform the study nurse/co-ordinator of covid-19 testing 7. 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: 1. fever equal to or greater than 38 degrees celsius or 2. tachypnoea respiratory rate equal to or greater than 20 breaths/min or 3. 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 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 by participant or proxy capable of giving consent 5. laboratory virological confirmation of sars-cov-2 by pcr as per local laboratory assays and covid-19 diagnosis prior to randomisation 6. hospitalised but has not required mechanical ventilation 7. 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). 8. 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. 9. 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.