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Trial - CTRI/2021/12/038851


Column Value
Trial registration number CTRI/2021/12/038851
Full text link
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Sivakumar Vaidyanathan

Contact
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

subramanian.l101@biocon.com

Registration date
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2021-12-22

Recruitment status
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

1 Male or female adults above �18 years. <br/ > 2 Informed consent for participation in the study by patient or their legally acceptable representative. <br/ > 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) <br/ > 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. <br/ > 5 A confirmed virological diagnosis of SARS-CoV2 infection with RT-PCR <br/ > 6 Patients with no known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). <br/ > 7 Women of childbearing potential (WOCP) with negative pregnancy test or are not breastfeeding at screening. <br/ > 8 Males and WOCP agreeing to use adequate contraception (e.g., double barrier contraception) for 130 days from randomisation. <br/ >

Exclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

1 Known severe allergic reactions to monoclonal antibodies. <br/ > 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). <br/ > 3 Known active systemic or pulmonary bacterial, fungal or viral (other than SARS-CoV-2) infection at the time of randomisation <br/ > 4 In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments. <br/ > 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. <br/ > 6 Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 3 months prior to screening. <br/ > 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. <br/ > 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. <br/ > 9 Requires renal dialysis, either acute or chronic, at the time of randomisation <br/ > 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. <br/ > 11 Absolute neutrophil count <1000/mm³ <br/ > 12 Platelet count <50,000/mm³ <br/ > 13 Absolute Lymphocyte count <500/mm³ <br/ >

Number of arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Biocon Limited

Inclusion age min
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

99

Countries
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Brazil;India

Type of patients
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate disease at enrollment

Severity scale
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

3: Moderate disease at enrollment

Total sample size
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

400

primary outcome
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Clinical composite endpoint comprising of: <br/ >1 Mortality at Day 28 <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/ >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/ >2. Day 1 through Day 28 <br/ >3. Day 1 through Day 28

Notes
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

Arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 691, "treatment_name": "Itolizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]