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Clinical Trials/CTRI/2021/12/038851
CTRI/2021/12/038851OtherPhase 3

A Phase 3, multi-centre, randomised, double-blind, placebo-controlled, study to evaluate the efficacy and safety of Itolizumab in hospitalised patients with COVID-19 requiring oxygen therapy

Biocon Limited0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Other
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1 Male or female adults above ââ?°Â¥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 Ã?°C / 100.4 Ã?°F anytime during the last 2 days, OR increased markers of inflammation (CRP ââ?°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.

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-Ã?± 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/mmÃ?³
  • •12 Platelet count <50,000/mmÃ?³
  • •13 Absolute Lymphocyte count <500/mmÃ?³

Investigators

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