Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tocilizumab and Current Standard of Care: Dose: 6 mg/kg (up to a maximum of 480 mg), Frequency: Once, Route of Administration: Intravenous Infusion, Total duration of administration: 1
Sponsors
Medanta Institute of Education and Research MIER
Eligibility
Inclusion criteria
Inclusion criteria: I. Male or female subjects who are >=18 years of age, on the day of signing informed consent. II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure. III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid). IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%-94%; and severe disease - respiratory rate >= 30/minute and/or SpO2
Exclusion criteria
Exclusion criteria: I. Known severe allergic reactions to TCZ or other monoclonal antibodies II. Active tuberculosis (TB) infection. III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. VI. Participating in other drug clinical trials VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. X. Definite diagnosis of rheumatic immune related diseases. XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline XII. Absolute Neutrophil count XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects showing progressive COVID 19 disease from moderate to severe, or from severe disease to deathTimepoint: Up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to clinical improvement (TTCI),defined as a National Early Warning SCORE2(NEWS2) of lesser and equal to 2, maintained for 24 hours 2.Proportion of subjects showing Improvement (â?¥1 grade) of CRS 3.Incidence of Mechanical Ventilation 4.Ventilator Free days to day 28 5.Organ Failure-free days to day 28 6.Incidence of Intensive Care (ICU) stay 7.Duration of ICU stay 8.ICU free days 9.Time to Clinical Improvement of COVID-19 grade 10.Mortality rateTimepoint: 1.Upto 28 Days 2.Upto 28 Days 3.Upto 28 Days 4.Upto Day 28 5.Upto Day 28 6.Upto 28 days 7.Upto 28 days 8.Upto 28 days 9.Upto 28 days 10.Days 7, 14, 21 and 28 | — |
Countries
India
Contacts
Public ContactKuldeep K Chauhan
Medanta Institute of Education and Research (MIER)
Outcome results
None listed