COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04534725

Rachel Woolstencroft

rachel.woolstencroft@petermac.org

2020-09-01

Recruiting

RCT

Randomized

Sequential assignment

Blind label

single-center

Prevention

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.

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 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

4

Peter MacCallum Cancer Centre, Australia

18

100

Australia

High risk patients

N/A

2282

time to clinical improvement or discharge from hospital assessed using medical records;incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records;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 assessed using local standard of care testing;incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing;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 .

None

Phase 3

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