{"preliminary_commentary":{"by_channel":{"podcast":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"C-SMART","nct_id":"NCT04534725","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=c-smart-nct04534725. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"C-SMART","arms":[{"description":"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.\n\nParticipants 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.\n\nParticipants will be followed during the 3-month treatment for incidence of COVID-19 and other respiratory infections.","label":"prophylaxis","type":"EXPERIMENTAL"},{"description":"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.\n\nParticipants 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\n\nParticipants will be followed for 28 days for incidence of COVID-19 and other respiratory infections.","label":"Post-Exposure Prophylaxis","type":"EXPERIMENTAL"},{"description":"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.\n\nParticipants 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\n\nParticipants will be followed for 60 days to assess effectiveness and safety.","label":"Moderate COVID-19 infection","type":"EXPERIMENTAL"},{"description":"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.\n\nParticipants 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.\n\nParticipants will be followed for 60 days to assess effectiveness and safety.","label":"Severe COVID-19 infection","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-04-19","type":"ACTUAL"},"conditions":["Cancer","Covid19","Respiratory Viral Infection"],"enrollment":{"count":441,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Interferon alfa","otherNames":[],"type":"DRUG"},{"name":"Selinexor","otherNames":[],"type":"DRUG"},{"name":"Lenzilumab","otherNames":[],"type":"DRUG"}],"last_update":"2023-08-24","lead_sponsor":"Peter MacCallum Cancer Centre, Australia","official_title":"COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; C-SMART Study.","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-11-28","type":"ACTUAL"},"primary_outcomes":[{"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)","timeFrame":"3 months from baseline."},{"measure":"incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing","timeFrame":"3 months from baseline."},{"measure":"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 .","timeFrame":"28 days from baseline"},{"measure":"incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing","timeFrame":"28 days from baseline"},{"measure":"incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records","timeFrame":"60 days from baseline"},{"measure":"time to clinical improvement or discharge from hospital assessed using medical records","timeFrame":"28 days from baseline"}],"references":[{"citation":"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.","pmid":"40874769","type":"DERIVED"},{"citation":"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.","pmid":"34473343","type":"DERIVED"}],"start_date":{"date":"2020-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;","url":"https://clinicaltrials.gov/study/NCT04534725"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/c-smart-nct04534725"}