Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Patient will be given itolizumab 1.6mg/kg in a single dose: GROUP2:Patient will be given itolizumab 1.6mg/kg in a single dose
Intervention2: Patient will be given Tocilizumab 8mg/kg in
Sponsors
AIIMS Patna
AIIMS Patna
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 to 60 years 2. Virological diagnosis of SARS-CoV2 infection (PCR) 3. Patients who are in moderate ARDS following COVID-19 infection, as defined by PaO2/FiO2 ratio of deterioration from the immediate previous value within 24hrs in patient having po2/fio2 >200. 4. Baseline serum ferritin level >=400ng/mL or IL-6 levels greater than 4 times the upper limit of normal (ULN) would be included.
Exclusion criteria
Exclusion criteria: 1. Known case of severe allergic reactions to monoclonal antibodies 2. Active tuberculosis (TB) infection 3. History of inadequately treated tuberculosis or latent tuberculosis 4. Have received oral anti-rejection or immune- suppressive drugs within the past 6 months 5. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 6. Patients with known history of Hepatitis B, Hepatitis C or HIV 7. Absolute Neutrophils count (ANC) 8. Platelets 9. Absolute Lymphocyte count (ALC): 10. Very severe ARDS Pao2/Fio2=5 11. ARDS due to others secondary infection/ bacterial sepsis (High procalcitonin value) 12. Those patient who will be recruited for another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P/F ratio [ baseline, during treatment before every dose after 12 hr post dose,] daily for one week,14th dayTimepoint: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Biomarkers (IL-6, Serum ferritin, CRP)Baseline, 72hr post dose, 7th day 2.Radiological response (chest x ray ) using Brixia score : At baseline, after 7th day, 14th day 3.Duration of hospitalization [ Time Frame: One Month ]from baseline up to patients discharge (up to 1 month) 4.Remission of respiratory symptoms [ Time Frame:up to 1 month] 5.Requirements of second drug dose and total cost 6.Any adverse effect? 7.One-month mortality rate between the two groups Timepoint: 3 month | — |
Countries
India
Contacts
Public ContactDr Poonam kumari
AIIMS Patna
Outcome results
None listed