Other substances

Itolizumab

A humanized anti-CD6 IgG1 monoclonal antibody.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Itolizumab is a humanized monoclonal IgG1 antibody targeting CD6 antigen. It downregulates pro-inflammatory cytokine production by T-helper 17 cells. Itolizumab is used for treatment of chronic plaque psoriasis (Jayaraman, 2013).

Itolizumab on DrugBank
Itolizumab on Wikipedia

Synonyms

Alzumab

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Use of a Humanized Anti-CD6 Monoclonal Antibody (Itolizumab) in Elderly Patients with Moderate COVID-19 Elderly Antibody Moderate severity Cohort study	Elderly patients	3.54	Timely use of itolizumab, in combination with other antiviral and anticoagulant therapies, is associated with a reduction in the COVID-19 disease worsening and mortality. Observed (short observational window) decrease in IL-6 levels. Sample size: 19 + 53 control. Dosage: 200 mg IV; a second 200 mg dose in majority of patients.	Oct/26/2020
An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients Severe severity Elderly Critical severity Antibody Moderate severity Cohort study	Elderly patients	2.80	Decreased IL-6 levels in severe to critical COVID-19 patients and stabilized the levels in moderate cases. Sample size: 24. Dosage: 1-3 IV doses of 200 mg.	Nov/14/2020
Treatment of COVID‐19 patients with the anti‐CD6 antibody itolizumab Severe severity Non-randomized non-controlled open trial Critical severity Antibody Moderate severity	Patients	6.46	Administration of the antibody resulted in stabilisation or improvement of respiratory functions in the majority of moderate to severe patients with 14-day mortality being relatively low given the late initiation of the treatment. Decrease of IL-6 levels was observed in patients with 27.4 pg/mL IL-6 concentration prior to the treatment. The patients with lower state of inflammation at the baseline were not observed to have significantly elevated IL-6 levels after the treatment. Sample size: 70. Dosage: A single 200 mg IV dose; optional second dose (58.8%; 3 days (median) after the first one); optional third dose (4.3%; 5 days (median) after the second one).	Nov/25/2020
Off-label Use of Itolizumab in Patients with COVID-19 ARDS: Our Clinical Experience in a Dedicated COVID Center. ARDS Severe severity Protein factor Antibody Cohort study	ARDS patients		1-month mortality was lower in patients who had received the drug. Sample size: 20 + 130 control. Dosage: 1.6 mg/kg.	Mar/29/2021

AI-suggested references

Link	Publication date
Itolizumab, an anti-CD6 monoclonal antibody, as a potential treatment for COVID-19 complications.	Jul/29/2020
An anti-CD6 antibody for the treatment of COVID-19 patients with cytokine-release syndrome: report of three cases	Jan/05/2021
Off-label Use of Itolizumab in Patients with COVID-19 ARDS: Our Clinical Experience in a Dedicated COVID Center	Oct/10/2020
A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19	Apr/09/2021
Treatment of COVID-19 patients with the anti-CD6 antibody itolizumab.	Nov/25/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04605926	A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19	Withdrawn	Phase 3	Nov/01/2020	Jun/01/2021
Alternative id - EQ001-20-001 Interventions - Biological: EQ001\|Biological: EQ001 Placebo Study type - Interventional Study results - No Results Available Locations - Inv Site CO01, Medellín, Colombia Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 0 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Proportion of subjects who have recovered at Day 28.\|Proportion of subjects deceased or requiring mechanical ventilation at Day 28.\|Proportion of subjects deceased at Day 28.
NCT04475588	Efficacy and Safety of Itolizumab in COVID-19 Complications	Completed	Phase 2	May/01/2020	Jul/07/2020
Alternative id - ITOLI-C19-02-I-00 Interventions - Drug: Itolizumab IV infusion\|Drug: Best supportive care (BSC) Study type - Interventional Study results - Has Results Locations - Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,, Mumbai, India\|Seth GS Medical College and KEM Hospital, Mumbai, India\|MAMC medical college and Lok Nayak Jai Prakash Narayan Hospital hospital, New Delhi, India\|All India Institute Of Medical Sciences, New Delhi, India Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 32 Age - 18 Years to 99 Years (Adult, Older Adult) Outcome measures - One-month Mortality Rate Between the Two Arms\|Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2\|Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)\|Reduction in Proportion of Patients on Non-invasive Ventilation\|Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2\|Reduction in Proportion of Patients- Invasive Mechanical Ventilation\|Reduction in Proportion of Patients-High Flow Nasal Oxygen\|Mean Change From Baseline in Ferritin\|Mean Change From Baseline in LDH\|Mean Change From Baseline in CRP (C-reactive Protein)\|Mean Change From Baseline D-Dimer\|Mean Change From Baseline of Absolute Lymphocyte Count\|Biomarkers (IL-6, TNF-a)\|Mean PaO2 (Partial Pressure of Oxygen) / FiO2 (Fraction of Inspired Oxygen, FiO2) Ratio (or P/F Ratio)\|Number and Percentage of Patients With Radiological Response

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