Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Intervention: 1.6 mg/kg given as IV infusion as a starting dose. Additional dose of 0.8mg/Kg can be administered after 7 days based on the physician�s discretion.
Control Interve
Sponsors
Biocon Biologics India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adults above >18 years 2. Informed consent for participation in the study 3. Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR) 4. Hospitalized with ARDS due to clinical worsening 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 7. Baseline serum ferritin level � 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available
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. Patient on invasive mechanical ventilator support 6. Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months 7. Patient on treatment of anti-IL-6 as a part of supportive care 8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 9 Patients with known history of Hepatitis B, Hepatitis C or HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)Timepoint: Up to 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers (IL-6 and TNF-a)Timepoint: up to 1 month;Change in inflammatory markers like CRP (C-reactive protein) level, Serum Ferritin, D- dimer and LDHTimepoint: Up to 1 month;Clinical Status as improvement of 1 and 2 point on an ordinal scaleTimepoint: up to 1 month;Duration of hospitalizationTimepoint: Up to 1 month;Incidence, nature and severity of adverse events causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)Timepoint: Up to 1 month;One-month mortality rateTimepoint: Up to 1 month;PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen) ratioTimepoint: Up to 1 month;Proportion of patients without deterioration of lung function as measured by stable/ improved SpO2 without increasing FiO2Timepoint: Up to 1 month;Remission of respiratory symptoms (time to independence from non-invasive mechanical ventilation calculated in days)Timepoint: Up to 1 month;Remission of respiratory symptoms(time to independence from oxygen therapy in days)Timepoint: Up to 1 month | — |
Countries
India
Contacts
Public ContactSivakumar Vaidyanathan
Biocon Biologic India Limited
Outcome results
None listed