Single arm study of Itolizumab in the treatment of COVID 19 complication.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027941
- Lead Sponsor
- Biocon Biologics India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female adults above >18 years
2. Informed consent for participation in the study
3. Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR)
4. Hospitalized with ARDS due to clinical worsening of COVID-19 infection
5. Oxygen saturation at rest in ambient air �94%
6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of � 200
7. Baseline serum ferritin level � 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available
1. Known severe allergic reactions to monoclonal antibodies
2. Active tuberculosis (TB) infection
3. History of inadequately treated tuberculosis or latent tuberculosis
4. In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments
5. Patient on invasive mechanical ventilator support
6. Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months
7. Patient on treatment of anti-IL-6 as a part of supportive care
8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
9 Patients with known history of Hepatitis B, Hepatitis C or HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)Timepoint: Up to 1 month
- Secondary Outcome Measures
Name Time Method