Efficacy and Safety of Itolizumab in COVID-19 Complications

A Multi-Centre, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/024959

Enrollment

Registered

2020-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J70- Respiratory conditions due to other external agents

Interventions

Intervention1: Arm A Best supportive care with Itolizumab: Start at 1.6 mg/kg dose iv infusion, if well tolerated and improvement in patient observed, investigator has the discretion to continue with

oxygen therapy, will be administered. The best supportive care will be as per institution standard

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female adults above 18 years (not tested in children yet) 2. Informed consent for participation in the study 3. Virological diagnosis of SARS-CoV2 infection (PCR) 4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection 5. Oxygen saturation at rest in ambient air 6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of more than 25% detoriation from the immediate previous value.

Exclusion criteria

Exclusion criteria: 1. Known severe allergic reactions to monoclonal antibodies 2. Active tuberculosis (TB) infection 3. History of inadequately treated tuberculosis or latent tuberculosis 4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments 5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months 6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) 7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 8. Patients with known history of Hepatitis B, Hepatitis C or HIV 9. Absolute Neutrophils count (ANC) 10. Platelets 11. Absolute Lymphocyte count (ALC):

Design outcomes

Primary

Measure	Time frame
1 one month mortality rate 2 Proportion of pts with deterioration of lung function as measured by â?¢ Stable SpO2; PaO2 without increasing FiO2 3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation 4 Reduction in proportion of pts who need â?¢ NIV â?¢ IMV â?¢ HFNO 5 Time of duration of mechanical ventilation, for pts needing intubation 6 Change in inflammatory markers CRP, d-Dimer, ferritin Timepoint: up to One-month	—

Measure

Time frame

1 one month mortality rate 2 Proportion of pts with deterioration of lung function as measured by â?¢ Stable SpO2; PaO2 without increasing FiO2 3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation 4 Reduction in proportion of pts who need â?¢ NIV â?¢ IMV â?¢ HFNO 5 Time of duration of mechanical ventilation, for pts needing intubation 6 Change in inflammatory markers CRP, d-Dimer, ferritin Timepoint: up to One-month

—

Secondary

Measure	Time frame
Biomarkers (IL-6, TNF-a)Timepoint: up to One-month;Duration of hospitalizationTimepoint: up to One-month;Lymphocyte countTimepoint: up to One-month;PaO2 / FiO2 ratioTimepoint: up to One-month;Radiological responseTimepoint: up to One-month;Remission of respiratory symptomsTimepoint: up to One-month;Treatment-related side effects as assessed by CTCAETimepoint: up to One-month	—

Countries

India

Contacts

Public ContactSivakumar Vaidyanathan

Biocon Biologic India Limited

subramanian.l101@biocon.com08028085305

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026