Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Hetero-Tocilizumab: Hetero-Tocilizumab 8mg/kg (maximum 800mg) once on Day 1. This is a single dose administration intravenously over 60 min infusion
Control Intervention1: RMP-Tocilizum
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent. 2. Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen 3. Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 4. Patients with elevated IL-6 ( >40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP ( >75mg/L) and ferritin 5X ULN
Exclusion criteria
Exclusion criteria: 1. Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation. 2. Patients requiring intubation and mechanical ventilation 3. Patients with ALT/AST >= 5 x upper limit of normal (ULN) 4. Patients with platelet counts 5. Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months 6. Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer 7. Evidence of multiorgan failure 8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization 9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative proportion of patients requiring mechanical ventilationTimepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of TEAEs (clinical and laboratory) during the studyTimepoint: All Visits;Mortality Rate during the studyTimepoint: Day 14 and 28;Proportion of patients discontinued the study due to adverse eventsTimepoint: All Visits;Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO)Timepoint: Day 14 and 28;Time to 2-point decrease in ordinal scale (as recommended by WHO) from randomization.Timepoint: Up to Day 28 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed