Other substances

Leronlimab

A monoclonal antibody targeting CCR5.

Phase of research

Potential treatment - clinical evidence

How it helps

Other treatment

Drug status

Used to treat other disease

2
 Supporting references
0
 Contradictory references
4
 AI-suggested references
5
 Clinical trials

General information

Leronlimab is a humanized monoclonal antibody that binds CCR5 chemokine receptor. Inhibition of CCR5-mediated signalling reduces activation of NF-κB and IL-6. CCR5 is also used by HIV as a fusion coreceptor. Leronlimab thus has anti-HIV, immunomodulatory, and antineoplastic properties (DrugBank).

Leronlimab on Wikipedia

Synonyms

PRO-140

 

Supporting references

Link Tested on Impact factor Notes Publication date
Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19
Patients May/05/2020
Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab
IL-6 Severe severity Critical severity Antibody Cohort study 		Patients 8.31

High recovery rate with fast clinical improvement in some patients. In a subset of patients biochemical markers of inflammation improved significantly only after second dose. Sample size: 23. Dosage: 700mg subcutaneous injection (second dose after 7 days in 74% of patients).

 Oct/20/2020

AI-suggested references

Link Publication date
Reduced Cell Surface Levels of C-C Chemokine Receptor 5 and Immunosuppression in Long Coronavirus Disease 2019 Syndrome.
Jan/13/2021
Disruption of CCR5 signaling to treat COVID-19-associated cytokine storm: Case series of four critically ill patients treated with leronlimab.
Jan/06/2021
CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+ T Cells Following Treatment With the Anti-CCR5 Antibody Leronlimab
Feb/04/2021
CCR5 inhibition in critical COVID-19 patients decreases inflammatory cytokines, increases CD8 T-cells, and decreases SARS-CoV2 RNA in plasma by day 14.
Nov/10/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT04343651 Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 Completed Phase 2 Apr/01/2020 Sep/20/2021
  • Alternative id - CD10_COVID-19
  • Interventions - Drug: Placebos|Drug: Leronlimab (700mg)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - University of California, Los Angeles, Los Angeles, California, United States|Palmtree Clinical Research, Inc., Palm Springs, California, United States|Eisenhower Health, Rancho Mirage, California, United States|Yale, New Haven, Connecticut, United States|Center for Advanced Research & Education (CARE), Gainesville, Georgia, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Atlantic Health System Hospital, Morristown, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|White Plains Hospital, White Plains, New York, United States|Novant Health, Charlotte, North Carolina, United States|Ohio Health, Columbus, Ohio, United States|Oregon Health and Science University, Portland, Oregon, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 86
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)|Time to clinical resolution (TTCR)|Change from baseline in National Early Warning Score 2 (NEWS2)|Change from baseline in pulse oxygen saturation (SpO2)|Change from baseline in the patient's health status on a 7-category ordinal scale|Incidence of hospitalization|Duration (days) of hospitalization|Incidence of mechanical ventilation supply|Duration (days) of mechanical ventilation supply|Incidence of oxygen use|Duration (days) of oxygen use|Mortality rate|Time to return to normal activity
NCT04678830 COVID-19 Long-Haulers Study Completed Phase 2 Mar/01/2021 Jul/08/2021
  • Alternative id - CD15_COVID-19
  • Interventions - Drug: Placebos|Drug: Leronlimab (700mg)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Arthritis & Rheumatic Disease Specialties, Aventura, Florida, United States|Center for Advanced Research & Education (CARE), Gainesville, Georgia, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 56
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Changes from baseline in daily COVID-19-related symptom severity score through Day 56.|Duration of COVID-19 associated symptoms from start of study treatment (Day 0) based on self-assessment using daily symptom diary.|Number of symptom-free days of COVID-19 associated symptoms that were present at the start of study treatment (Day 0) based on self-assessment using daily symptom diary.|Progression (or worsening) of COVID-19-associated symptoms through Day 56 compared to baseline.|• Change from baseline in PROMIS® Fatigue Score at Days 28 and 56 and 56.|Change from baseline in PROMIS® Cognitive Function Score at Days 28 and 56|Change from baseline in PROMIS® Sleep Disturbance Score at Days 28 and 56.|Duration (days) of hospitalization during the treatment phase|Incidence of hospitalization during the treatment phase
NCT04901676 Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia Recruiting Phase 3 Sep/09/2021 Feb/01/2022
  • Alternative id - ARO_21_018_001
  • Interventions - Drug: Leronlimab|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clinica São Roque, Ipiaú, BA, Brazil|Instituto de Ensino e Pesquisa do Hospital da Bahia, Salvador, BA, Brazil|Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel, Salvador, BA, Brazil|Hospital do Coração do Brasil, Brasília, DF, Brazil|Hospital Vitoria, Vitória, ES, Brazil|Hospital Felicio Rocho, Belo Horizonte, MG, Brazil|Santa Casa de Passos, Passos, MG, Brazil|Hospital São Lucas Copacabana, Rio De Janeiro, RJ, Brazil|Instituto Atena de Pesquisa Clínica, Natal, RN, Brazil|Hospital São Vicente de Paulo, Passo Fundo, RS, Brazil|Hospital Mãe de Deus, Porto Alegre, RS, Brazil|Irmandade da Santa Casa de Misericórdia Porto Alegre, Porto Alegre, RS, Brazil|Centro de Pesquisa Clínica do Coração, Aracaju, SE, Brazil|Fundação PIO XII, Barretos, SP, Brazil|Irmandade do Sr. Bom Jesus dos Passos da Santa Casa de Misericórdia de Bragança Paulista, Bragança Paulista, SP, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SP, Brazil|Santa Casa de Santos, Santos, SP, Brazil|BP Mirante, Sao Paulo, SP, Brazil|Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José Do Rio Preto, SP, Brazil|Associação Beneficente Síria - Hospital do Coração (HCor), São Paulo, SP, Brazil|Hospital 9 de Julho, São Paulo, SP, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil|Hospital Beneficência Portuguesa, São Paulo, SP, Brazil|Hospital M'Boi Mirim, São Paulo, SP, Brazil|Hospital Santa Paula, São Paulo, SP, Brazil|Santa Casa de Votuporanga, Votuporanga, São Paulo, Brazil|Hospital Israelita Albert Einstein, Sao Paulo, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 612
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Cumulative incidence of death or respiratory failure until day 28|Time to clinical recovery|Death or intubation until day 28|Proportion of patients clinically recovered|All-cause mortality|Proportion of patients discharged alive|Clinical status|Length of hospital stay
NCT04901689 Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation Recruiting Phase 3 Oct/23/2021 Feb/01/2022
  • Alternative id - ARO_21_018_002
  • Interventions - Drug: Leronlimab|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clinica São Roque, Ipiaú, BA, Brazil|Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel, Salvador, BA, Brazil|Hospital do Coração do Brasil, Brasilia, DF, Brazil|Hospital Dr Jayme dos Santos Neves, Laranjeiras, ES, Brazil|Santa Casa de Misericórdia de Passos, Passos, MG, Brazil|Hospital 9 de Julho, Sao Paulo, Please Select, Brazil|Hospital São Lucas Copacabana, Rio De Janeiro, RJ, Brazil|Instituto Atena de Pesquisa Clínica, Natal, RN, Brazil|Hospital São Vicente de Paulo, Passo Fundo, RS, Brazil|Hospital Mãe de Deus, Porto Alegre, RS, Brazil|Irmandade da Santa Casa de Misericórdia Porto Alegre, Porto Alegre, RS, Brazil|Centro de Pesquisa Clínica do Coração, Aracaju, SE, Brazil|Fundação PIO XII, Barretos, SP, Brazil|Irmandade do Sr. Bom Jesus dos Passos da Santa Casa de Misericórdia de Bragança Paulista, Bragança Paulista, SP, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SP, Brazil|Hospital Santa Ignes, Indaiatuba, SP, Brazil|Hospital Alemão Oswaldo Cruz, Sao Paulo, SP, Brazil|Hospital Beneficência Portuguesa, Sao Paulo, SP, Brazil|Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José Do Rio Preto, SP, Brazil|BP Mirante, São Paulo, SP, Brazil|Santa Casa de Votuporanga, Votuporanga, SP, Brazil|Hospital Israelita Albert Einstein, Sao Paulo, Brazil|Hospital M'Boi Mirim, São Paulo, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 316
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Cumulative proportion of clinical recovery|Proportion of patients clinically recovered|All-cause mortality|Proportion of patients discharged alive|Clinical Status|Duration of invasive mechanical ventilation or ECMO|Length of hospital stay|Length of ICU stay
NCT04347239 Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) Active, not recruiting Phase 2 Apr/15/2020 Jun/15/2022
  • Alternative id - CD12_COVID-19
  • Interventions - Drug: Placebos|Drug: Leronlimab (700mg)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Advanced Cardiovascular, LLC, Alexander City, Alabama, United States|St. Jude Medical Center, Fullerton, California, United States|UCLA, Los Angeles, California, United States|James A. Haley Veterans' Hospital, Tampa, Florida, United States|Center for Advanced Research & Education (CARE), Gainesville, Georgia, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|St. Barnabas, Livingston, New Jersey, United States|Atlantic Health System Hospital, Morristown, New Jersey, United States|Holy Name Medical Center, Teaneck, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|New York Community Hospital of Brooklyn, Brooklyn, New York, United States|Novant Health, Winston-Salem, North Carolina, United States|Ohio Health, Columbus, Ohio, United States|Good Samaritan Hospital Corvallis, Corvallis, Oregon, United States|Oregon Health and Sciences University, Portland, Oregon, United States|Baylor Scott & White Research Institute, Dallas, Texas, United States|Baylor College of Medicine, Houston, Texas, United States|University of Texas, Houston, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 394
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - All-cause mortality at Day 28|All-cause mortality at Day 14|Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)|Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)|Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
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