Evaluate the efficacy and safety of Itolizumab in hospitalised patients with COVID-19 requiring oxygen therapy
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J70- Respiratory conditions due to other external agents
- Registration Number
- CTRI/2021/12/038851
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1 Male or female adults above �18 years.
2 Informed consent for participation in the study by patient or their legally acceptable representative.
3 Hospitalised patients with COVID-19 infection receiving systemic steroids with scores 5 or 6 on 8-point clinical scale (hospitalised and requiring supplemental oxygen / requiring non-invasive ventilation or use of high-flow oxygen devices but not on invasive mechanical ventilation)
4 An inflammatory, phenotype defined by a body temperature greater than 38 �°C / 100.4 �°F anytime during the last 2 days, OR increased markers of inflammation (CRP â�¥ 3 ULN as per local lab) at screening.
5 A confirmed virological diagnosis of SARS-CoV2 infection with RT-PCR
6 Patients with no known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
7 Women of childbearing potential (WOCP) with negative pregnancy test or are not breastfeeding at screening.
8 Males and WOCP agreeing to use adequate contraception (e.g., double barrier contraception) for 130 days from randomisation.
1 Known severe allergic reactions to monoclonal antibodies.
2 Has active tuberculosis or known history of inadequately treated tuberculosis or latent tuberculosis(based on the the guidance given in protocol on excluding tuberculosis patients).
3 Known active systemic or pulmonary bacterial, fungal or viral (other than SARS-CoV-2) infection at the time of randomisation
4 In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments.
5 Patient receiving IMV at the time of randomisation or in the opinion of investigator, progression to IMV is highly probable in next 24 hours.
6 Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 3 months prior to screening.
7 Participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives prior to randomisation.
8 Patients treated with IL-6 inhibitors, example: tocilizumab or other biologics with anti-inflammatory action (e.g., TNF-�± inhibitors, anti-IL17A) or bevacizumab or JAK inhibitors (e.g. Baricitinib, Tofacitinib) or immunoglobulin for COVID-19 including other immunomodulatory biologic drugs with a positive opinion for emergency use or for compassionate use.
9 Requires renal dialysis, either acute or chronic, at the time of randomisation
10 Any serious inherited disorder, medical condition or abnormality of clinical laboratory tests that, in the investigatorââ?¬•s judgement, precludes the patientââ?¬•s safe participation in and completion of the study.
11 Absolute neutrophil count <1000/mm�³
12 Platelet count <50,000/mm�³
13 Absolute Lymphocyte count <500/mm�³
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical composite endpoint comprising of: <br/ ><br>1 Mortality at Day 28 <br/ ><br>2 Clinical deterioration, defined as progression to a higher ordinal score from enrolment scores of 5 or 6 during the period of 28 days. <br/ ><br>3 Time to recovery by Day 28, defined as time to get to a score of 3 or below in the 8-point ordinalscale plus sustained recovery.Timepoint: 1. Day 1 through Day 28 <br/ ><br>2. Day 1 through Day 28 <br/ ><br>3. Day 1 through Day 28
- Secondary Outcome Measures
Name Time Method