Efficacy and Safety of Itolizumab in COVID-19 Complications

Biocon Limited32 enrolled

Overview

Randomized, Parallel Group, Active Controlled Trial

This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study. All eligible patients entering into the study will be randomized in 2:1 ratio to receive the treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each patient will undergo the treatment based on their assigned treatment for a month along with battery of tests that includes, but not limited to, cytokines and chemokine, along with recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS. As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing complications such as Cytokine Release Syndrome is not known. However, findings from this study may be beneficial to the society at a large at the National and International Level.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome Cytokine Release Syndrome Covid19

Interventions

Itolizumab IV infusionDRUG

First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks. BSC: similar to Arm B

Best supportive care (BSC)DRUG

Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Key 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 ≤94% 6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of \< 200 Key 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) \<1000 / mm3 10. Platelets \<50,000 / mm3 11. Absolute Lymphocyte count (ALC): \<500/mm3

Locations (4)

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

Outcomes

Primary Outcomes

One-month Mortality Rate Between the Two Arms

1-month mortality is defined as the proportion of patients who met fatal outcome event by Day 30

Time frame: One-month

Lung Function Assessment - Proportion of the Patients With Stable or Improved SpO2 Without Increasing FiO2

Stable SpO2: Defined as number of patients with absence of increase in FiO2 to maintain SpO2 ≥ 92% Improvement of SpO2: Defined as number of patients with decrease in FiO2 to maintain SpO2 \> 92%

Time frame: Day 7, Day 14, Day 21 & Day 30

Endo-tracheal Intubation/Invasive Mechanical Ventilation (IMV)

Number of patients needing Intubation/IMV post treatment

Time frame: Day 30

Reduction in Proportion of Patients on Non-invasive Ventilation

Reduction in proportion of Patients on Non-invasive Ventilation: defined as number of patient improved and shifted to Face mask, Nasal cannula, non-rebreather mask or off oxygen over time

Time frame: Baseline (Day 1), Day 7, Day 14 Day 21 & Day 30

Lung Function Assessment - Proportion of Patients With Stable PaO2 Without Increasing FiO2

Stable PaO2: Defined as number of patients with up to 10% change in PaO2/FiO2 ratio from baseline. Improvement of PaO2: Defined as number of patients with \> 10% improvement in PaO2/FiO2 ratio from baseline (including patients weaned off oxygen).

Time frame: Day 7, Day14, Day 21 & Day30

Reduction in Proportion of Patients- Invasive Mechanical Ventilation

Patient improved from invasive ventilation over time from baseline.

Time frame: Day7, Day14, Day21 & Day 30

Reduction in Proportion of Patients-High Flow Nasal Oxygen

Data from ClinicalTrials.gov

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