Other substances

Lenzilumab

An anti-granulocyte-monocyte colony-stimulating factor antibody.

Phase of research

Potential treatment - clinical evidence

How it helps

Other treatment

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Lenzilumab is an experimental recombinant monoclonal antibody targeting granulocyte-monocyte colony-stimulating factor (Temesgen et al., 2020) investigated as a chronic myelomonocytic leukemia candidate drug (DrugBank).

Lenzilumab on Wikipedia

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
First Clinical Use of Lenzilumab to Neutralize GM-CSF in Patients with Severe COVID-19 Pneumonia Severe severity Cytokine storm Preprint	Patients		In high-risk COVID-19 patients with severe pneumonia, GM-CSF neutralization with lenzilumab was safe and associated with improved clinical outcomes, oxygen requirement, and cytokine storm.	Jun/12/2020
GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia A Case-Cohort Study Severe severity Antibody Cohort study	Patients	6.94	Significantly shorter time to clinical improvement, reduced frequency of ARDS among treated patiens, and reduction in inflammatory markers. Sample size: 12 + 27 matched control. Dosage: 3 doses of 600 mg IV, 8 hours apart.	Nov/01/2020

AI-suggested references

Link	Publication date
Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with COVID-19 in the United States from the hospital perspective.	Dec/06/2021
In inpatients with COVID-19 who need supplemental oxygen, lenzilumab increased ventilation-free survival.	Apr/05/2022
Case report: use of lenzilumab and tocilizumab for the treatment of coronavirus disease 2019	Mar/24/2020
Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial	Aug/17/2021
Clinical and Economic Benefits of Lenzilumab Plus Standard of Care Compared with Standard of Care Alone for the Treatment of Hospitalized Patients with Coronavirus Disease 19 (COVID-19) from the Perspective of National Health Service England	Jan/23/2022
GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study.	Sep/03/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04583969	ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19	Active, not recruiting	Phase 2	Oct/19/2020	Oct/29/2022
Alternative id - 20-0013B Interventions - Biological: Lenzilumab\|Other: Placebo\|Drug: Remdesivir Study type - Interventional Study results - No Results Available Locations - University of Alabama at Birmingham School of Medicine - Infectious Disease, Birmingham, Alabama, United States\|The University of Arizona - Banner University Medical Center Tucson Campus - Tucson, Tucson, Arizona, United States\|University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States\|Kern Medical Center, Bakersfield, California, United States\|UCSF Fresno Center for Medical Education and Research - Clinical Research Center, Fresno, California, United States\|University of Southern California - Infectious Diseases, Los Angeles, California, United States\|Hoag Hospital Newport Beach, Newport Beach, California, United States\|Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases, Stanford, California, United States\|Penrose Hospital - Emergency Medicine, Colorado Springs, Colorado, United States\|St. Francis Medical Center, Colorado Springs, Colorado, United States\|St. Anthony Hospital, Lakewood, Colorado, United States\|St. Anthony Hospital North Health Campus, Westminster, Colorado, United States\|Nuvance Health Danbury Hospital - Infectious Disease, Danbury, Connecticut, United States\|Yale School of Medicine - The Anlyan Center for Medical Research & Education - Immunobiology, New Haven, Connecticut, United States\|Nuvance Health - Norwalk Hospital - Asthma Pulmonary and Critical Care Medicine, Norwalk, Connecticut, United States\|University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine, Gainesville, Florida, United States\|Mayo Clinic Florida, Jacksonville, Florida, United States\|Grady Memorial Hospital, Atlanta, Georgia, United States\|Emory Vaccine Center - The Hope Clinic, Decatur, Georgia, United States\|Cook County Health and Hospitals System - Ruth M Rothstein CORE Center, Chicago, Illinois, United States\|Rush University Medical Center, Chicago, Illinois, United States\|Great Lakes Clinical Trials, Chicago, Illinois, United States\|Carle Foundation Hospital, Urbana, Illinois, United States\|Northwestern Medicine - Central DuPage Hospital - Infectious Disease, Winfield, Illinois, United States\|Norton Healthcare, Louisville, Kentucky, United States\|University of Louisville - Division of Infectious Diseases, Louisville, Kentucky, United States\|Brigham and Women's Hospital - Infectious Diseases, Boston, Massachusetts, United States\|Boston Medical Center - Center for Infectious Diseases - Shapiro Center, Boston, Massachusetts, United States\|William Beaumont Hospital - Royal Oak Campus - Infectious Disease, Royal Oak, Michigan, United States\|Hennepin Healthcare Research Institute, Minneapolis, Minnesota, United States\|Mayo Clinic, Rochester - Infectious Diseases, Rochester, Minnesota, United States\|University of Nebraska Medical Center - Infectious Diseases, Omaha, Nebraska, United States\|Englewood Hospital, Englewood, New Jersey, United States\|Jacobi Medical Center, Bronx, New York, United States\|Montefiore Medical Center - Infectious Diseases, Bronx, New York, United States\|The State University of New York - University at Buffalo - Department of Medicine, Buffalo, New York, United States\|Mount Sinai School of Medicine - Medicine - Infectious Diseases, New York, New York, United States\|Nuvance Health - Vassar Brothers Medical Center, Poughkeepsie, New York, United States\|Stony Brook Medicine - Stony Brook University Hospita, Stony Brook, New York, United States\|Atrium Health ID Consultants & Infusion Care Specialists, Charlotte, North Carolina, United States\|Wake Forest Baptist Health - Infectious Diseases, Winston-Salem, North Carolina, United States\|University of Toledo Medical Center - Ruppert Clinic, Toledo, Ohio, United States\|St. Charles Health System - St. Charles Bend Hospital, Bend, Oregon, United States\|Doylestown Hospital, Doylestown, Pennsylvania, United States\|Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases, Hershey, Pennsylvania, United States\|Kent County Memorial Hospital, Warwick, Rhode Island, United States\|Monument Health - Clinical Research, Rapid City, South Dakota, United States\|Hendrick Health - Hendrick Medical Center, Abilene, Texas, United States\|Baptist Hospitals of Southeast Texas Site, Beaumont, Texas, United States\|Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants, Dallas, Texas, United States\|Methodist Hospital - Houston, Houston, Texas, United States\|University of Texas Health Science Center at San Antonio - Infectious Diseases, San Antonio, Texas, United States\|University of Utah - Infectious Diseases, Salt Lake City, Utah, United States\|West Virginia University - Infectious Diseases Clinic, Morgantown, West Virginia, United States\|Seoul National University Bundang Hospital - Division of Infectious Diseases, Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of\|Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 473 Age - Child, Adult, Older Adult Outcome measures - Occurrence of mechanical ventilation or death at any point through Day 29 in subjects with ordinal scores of 5 or 6 at baseline\|Change from baseline of inflammation and coagulation markers\|Change in alanine aminotransferase (ALT) over time\|Change in aspartate transaminase (AST) over time\|Change in creatinine over time\|Change in hemoglobin over time\|Change in international normalized ratio (INR) over time\|Change in platelets over time\|Change in total bilirubin over time\|Change in white blood cell (WBC) count with differential over time\|Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)\|Cumulative incidence of serious adverse events (SAEs)\|Duration of hospitalization\|Duration of new mechanical ventilation or extracorporeal membrane oxygenation (ECMO) use\|Duration of new non-invasive ventilation or high flow oxygen use during the study\|Duration of non-invasive ventilation/high flow oxygen use\|Incidence of discontinuation or temporary suspension of study product administration\|Incidence of new non-invasive ventilation or high flow oxygen use\|Incidence of ventilator/ extracorporeal membrane oxygenation (ECMO) use\|Mean change in the ordinal scale\|Subject Mortality\|Supplemental oxygen use\|Survival without mechanical ventilation through Day 29 in subjects with ordinal scores 5 or 6 at baseline.\|Survival without mechanical ventilation through Day 29.\|The proportion of alive and without respiratory failure\|Time to an improvement of one category using an ordinal scale\|Time to an improvement of two categories using an ordinal scale\|Time to death\|Time to Sustained Recovery in subjects with a baseline ordinal score of 5 or 6, CRP<150mg/L and age <85 years.\|Time to sustained recovery of subjects with any baseline score\|Ventilator/ extracorporeal membrane oxygenation (ECMO) use
NCT04351152	Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19	Active, not recruiting	Phase 3	May/05/2020	Mar/01/2021
Alternative id - HGEN003-06 Interventions - Biological: Lenzilumab\|Drug: Standard of Care Study type - Interventional Study results - No Results Available Locations - Mayo Clinic, Phoenix, Arizona, United States\|University of California, Irvine, Irvine, California, United States\|University of Southern California (USC) Medical Center, Los Angeles, California, United States\|USC - Los Angeles County Medical Center, Los Angeles, California, United States\|MedStar Washington Hospital Center, Washington, District of Columbia, United States\|Mayo Clinic, Jacksonville, Florida, United States\|AdventHealth Orlando, Orlando, Florida, United States\|Emory University, Atlanta, Georgia, United States\|St. Elizabeth Healthcare, Edgewood, Kentucky, United States\|Hennepin County Medical Center, Minneapolis, Minnesota, United States\|Mayo Clinic, Rochester, Minnesota, United States\|Dartmouth-Hitchcock, Lebanon, New Hampshire, United States\|Saint Barnabas Medical Center, Livingston, New Jersey, United States\|Mercy Medical Center, Rockville Centre, New York, United States\|Atrium Health, Charlotte, North Carolina, United States\|St. David's Healthcare, Austin, Texas, United States\|St. David's North Austin Medical Center, Austin, Texas, United States\|Texas Health, Dallas, Texas, United States\|Hospital Vera Cruz, Belo Horizonte, Minas Gerais, Brazil\|CPCLIN - Centro de Pesquisas Clínicas de Natal, Natal, Rio Grande Do Norte, Brazil\|Hospital São Lucas - PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil\|Sociedade Literaria e Caritativa Santo Agostinho, Criciúma, Santa Catarina, Brazil\|Hospital Dia do Pulmão, Blumenau, São Paulo, Brazil\|Hospital Guilherme Alvaro, Santos, São Paulo, Brazil\|Clinica de Alergia Martti Antila S/S LTDA, Sorocaba, São Paulo, Brazil\|CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA-EPP, São Bernardo do Campo, São Paulo, Brazil\|Escola Paulista de Medicina (UNIFESP), São Paulo, Brazil\|Hospital Heliópolis, São Paulo, Brazil\|Hospital São Luiz do Jabaquara/IDOR, São Paulo, Brazil Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 520 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Ventilator-free Survival\|Ventilator-free Days\|Duration of Intensive Care Unit (ICU) Stay\|Incidence of Invasive Mechanical Ventilation, ECMO and/or Death\|Time to Death\|All-cause Mortality\|Time to Recovery\|Incidence of severe acute respiratory distress syndrome (ARDS)\|Duration of Hospitalization\|Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale\|Number of Subjects Alive and Off Oxygen\|Percentage of Participants Experiencing Adverse Events\|Percentage of Participants Experiencing Serious Adverse Events\|Proportion of Subjects Discharged from Hospital\|Time to improvement in oxygenation for > 48 hours\|Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device)\|Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours\|Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale\|Duration of Time on Low-flow or High-flow Supplemental Oxygen
NCT04534725	COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;	Recruiting	Phase 3	Dec/17/2020	Dec/01/2021
Alternative id - Peter Mac ID 20/135 Interventions - Drug: Interferon alfa\|Drug: Selinexor\|Drug: Lenzilumab Study type - Interventional Study results - No Results Available Locations - Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 2282 Age - 18 Years and older (Adult, Older Adult) Outcome measures - 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 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 death and/or need for invasive or non-invasive ventilation. assessed using medical records\|time to clinical improvement or discharge from hospital assessed using medical records\|ARM 1: Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. Assessed using patient symptom Diary PRO tool\|ARM 1: 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: 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: Illness severity in case of confirmed COVID-19 diagnosed during the study period using WHO clinical progression scale\|ARM 1: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records\|ARM 1: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records\|ARM 1: Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR\|ARM 1: Incidence of death from any cause during the study period. assessed using patient medical records\|ARM 1: Incidence of testing for COVID-19 during the study period. assessed using medical records\|ARM 2 Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period. assessed with PRO and medical records.\|ARM 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: Illness severity in case of confirmed COVID-19 diagnosed during the study period. assessed using WHO clinical progression scale.\|ARM 2: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.\|ARM 2: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records\|ARM 2: Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.\|ARM 2: Incidence of testing for COVID-19 during the study period assessed using medical records\|ARM 3: Time to clinical improvement assessed using medical records.\|ARM 3: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale\|ARM 3: change to clinical condition assessed with Karnofsky Performance score\|ARM 3: Time to progression to severe COVID-19, defined by WHO ordinal scale\|ARM 3: Time to all-cause mortality\|ARM 3:Duration of hospitalisation assessed using medical records\|ARM 3: Duration of COVID-19 symptoms assessed using patient reported symptom diary.\|ARM 3: Duration of oxygen supplementation (days). assessed using medical records.\|ARM 3: change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)\|ARM 3: Safety and tolerability of selinexor using relevant medical records\|ARM 3: incidence of changes in blood results relevant to clinical improvement assessed using medical records\|ARM 4: Incidence of all cause death by day 28 and 60\|ARM 4: Time to all-cause mortality\|ARM 4: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale\|ARM 4: Incidence of ARDS assessed using medical records\|ARM 4: incidence of HLH. assessed using medical records\|ARM 4: Duration of hospitalisation. assessed using hospital medical records.\|ARM 4: Proportion discharged from hospital. assessed using medical records\|ARM 4: Incidence of mechanical ventilation up to day 28. assessed using medical records\|ARM 4: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records\|ARM 4: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.\|ARM 4: Incidence and duration of ICU admission. assessed using medical records\|ARM 4: incidence and duration of supplemental oxygen use. assessed using medical records\|ARM 4: Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours.\|ARM 4: incidence of non-invasive ventilation. assessed using medical records\|ARM 4: number of participants alive and off oxygen at day 60. assessed using medical records.\|ARM 4: proportion of participants who had improved oxygenation for >48 hours. assessed using medical records\|ARM 4: Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records\|ARM 4: incidence of SAEs based on NCI CTCAE v5 assessed using medical records\|ARM 4: change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.

Export (.csv)