Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: BP08 Tocilizumab: 400 mg of BP08 in 20 mL (20 mg/mL)
Control Intervention1: Tocilizumab (Actemra�®/RoActemra�®): 400 mg of BP08 in 20 mL (20 mg/mL)
Sponsors
CURATEQ BIOLOGICS PRIVATE LIMITED India
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be considered eligible when all the following criteria met: 1. Male or female adult patients. 18 to 65 years of age (both inclusive). 2. Hospitalized and Confirmed case of SARS-CoV-2 infection by rtPCR or rapid antigen test. 3. Severe COVID19 disease as defined as (any one of below) o Respiratory rate >30/min, Breathlessness o SpO2 4. Patient shows no signs of improvement in terms of oxygen requirement even after 24-48 hours of administration of steroids as per hospital records. 5. Evidence of systemic inflammation (any one of below) o CRP � 75mg/L. o IL-6 � 40 pg/mL 6. Informed consent for participation in the study either by Patient or LAR
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Tocilizumab or other monoclonal antibodies. 2. Evidence of active tuberculosis infection 3. Suspected or active bacterial, fungal, viral or other infection (Besides COVID-19) 4. Patient on invasive mechanical ventilator 5. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 6. Received prior treatment with oral anti-rejection or immune modulatory drugs (including Tocilizumab) within the previous 6 months. 7. Received immunomodulatory or biologics therapy (except steroids) as standard of care for the treatment of COVID-19 which could impact primary of secondary objectives of the study (including but not limited to itolizumab and TNF alpha inhibitors) 8. Patients with severe renal failure (eGFR 9. Any serious medical condition (including multiorgan failure) or abnormality of clinical laboratory tests that, in the investigatorââ?¬•s judgment, precludes the patient safe participation in and completion of the study. 10. Absolute Neutrophil count 11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times upper limit of normal detected at screening/baseline 12. Participating in other drug clinical trials 13. Pregnant or breastfeeding or positive pregnancy test in a pre-dose examination 14. History or known case of Hepatitis B, C or HIV 15. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative proportion of patients progressed by Day 28 (Progression is defined as requiring invasive mechanical ventilation, ECMO or met fatal outcome)Timepoint: Cumulative proportion of patients progressed by Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cumulative proportion of patients progressed by Day 14 (Progression is defined as requiring invasive mechanical ventilation, ECMO or met fatal outcome) 2. Proportion of patients with 2-point decrease in WHO ordinal scale by day 14 and 28 3. Time to discharge alive from hospital. 4. Time to recovery 5. Recovery rate by day 14 and 28 6. Change in inflammatory markers like IL-6, CRP (C-reactive protein) level, Serum Ferritin, D-dimer and LDHTimepoint: 1. Cumulative proportion of patients progressed by Day 14 2. Proportion of patients with 2-point decrease in WHO ordinal scale by day 14 and 28 3. Time to discharge alive from hospital. 4. Time to recovery 5. Recovery rate by day 14 and 28 6. Change in inflammatory markers like IL-6, CRP, Serum Ferritin, D-dimer and LDH | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed