Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J70- Respiratory conditions due to other external agents
Conditions
Interventions
Intervention1: Itolizumab: Itolizumab is presented as a sterile, white to pale yellow, preservative-free lyophilised cake in single-use 6R LYO (lyophilisation) glass vials stoppered with LYO stoppers
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 >= 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.
Exclusion criteria
Exclusion criteria: 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-α 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 investigatorâ??s judgement, precludes the patientâ??s safe participation in and completion of the study. 11 Absolute neutrophil count 12 Platelet count 13 Absolute Lymphocyte count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical composite endpoint comprising of: 1 Mortality at Day 28 2 Clinical deterioration, defined as progression to a higher ordinal score from enrolment scores of 5 or 6 during the period of 28 days. 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 2. Day 1 through Day 28 3. Day 1 through Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoint:- Clinical composite endpoint comprising of : 1. Mortality at Day 90. 2. Clinical deterioration, defined as progression to a higher ordinal score from enrolment score of 5 or 6 during the period of 90 days. 3. Time to recovery, defined as time to get to a score of 3 or below in the 8-point ordinal scale plus sustained recovery. Timepoint: Day 90;Secondary Endpoints:- 1.Mortality by Day 28, Day 60 and Day 90. 2.Time from randomisation to sustained recovery, defined as time to get to a score of 3 or below in the COVID-19 8-point ordinal scale plus sustained recovery.Timepoint: Day 1 through Day 90;3. Proportion of patients with clinical improvement (defined as either an improvement of â?¥2 points on a COVID-19 8-point ordinal scale or discharge from the hospital, whichever comes first) over time.Timepoint: Day 1 through Day 90;4. Cumulative rate of patients alive and without IMV by Day 90 from randomisationTimepoint: Day 1 through Day 90;5. Cumulative rate of patients going to IMV by Day 90 from randomisation.Timepoint: Day 1 through Day 90;6. Duration of hospitalisation.Timepoint: from randomisation up to patients discharge - Days of hospitalisation;7. Time to independence from oxygen therapy in days.Timepoint: from randomisation up to Day 90;8. Change from baseline in IL-6 and TNF-α.Timepoint: Baseline, 48 hours post dose, at Day 7 and then weekly until discharge;9, Change from baseline in levels of inflammatory markers like CRP, serum ferritin, D-dimer and LDH.Timepoint: Baseline, 48 hours post dose, at Day 7 and then weekly until discharge;10. Incidence, nature, severity of AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) and causality of AEs.Timepoint: Day 1 through Day 28 and up to Day 90 | — |
Countries
Brazil, India
Contacts
Public ContactSivakumar Vaidyanathan
Biocon Biologics Limited
Outcome results
None listed