Comparison of Tocilizumab Vs Itolizumab in covid 19 patient.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028325
- Lead Sponsor
- AIIMS Patna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <200, or more than 25%
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.
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) <1000 / mm3
8. Platelets <50,000 / mm3
9. Absolute Lymphocyte count (ALC): <500/mm3
10. Very severe ARDS Pao2/Fio2<=100 with PEEP>=5
11. ARDS due to others secondary infection/
bacterial sepsis (High procalcitonin value)
12. Those patient who will be recruited for
another study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method