CTRI/2021/09/036973尚未招募2 期
A Randomized, Open-Label, Parallel Group Study to Compare Efficacy and Safety of BP08 plus Standard of Care versus Reference Biologic Tocilizumab (Actemra�®/RoActemra�®) plus Standard of Care in Patients with Severe COVID-19 Disease
CURATEQ BIOLOGICS PRIVATE LIMITED India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects will be considered eligible when all the following criteria met:
- •1.Male or female adult patients. 18 to 65 years of age (both inclusive).
- •2.Hospitalized and Confirmed case of SARS-CoV-2 infection by rtPCR or rapid antigen test.
- •3.Severe COVID19 disease as defined as (any one of below)
- •o Respiratory rate >30/min, Breathlessness
- •o SpO2 < 90% on room air or requiring Oxygen therapy.
- •4.Patient shows no signs of improvement in terms of oxygen requirement even after 24-48 hours of administration of steroids as per hospital records.
- •5.Evidence of systemic inflammation (any one of below)
- •o CRP ââ?°Â¥ 75mg/L.
- •o IL-6 ââ?°Â¥ 40 pg/mL
- •6.Informed consent for participation in the study either by Patient or LAR
排除标准
- •1.Known hypersensitivity to Tocilizumab or other monoclonal antibodies.
- •2.Evidence of active tuberculosis infection
- •3.Suspected or active bacterial, fungal, viral or other infection (Besides COVID-19)
- •4.Patient on invasive mechanical ventilator
- •5.In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •6.Received prior treatment with oral anti-rejection or immune modulatory drugs (including Tocilizumab) within the previous 6 months.
- •7.Received immunomodulatory or biologics therapy (except steroids) as standard of care for the treatment of COVID-19 which could impact primary of secondary objectives of the study (including but not limited to itolizumab and TNF alpha inhibitors)
- •8.Patients with severe renal failure (eGFR < 30 mL/min) or on dialysis [eGFR should be calculated by using the Cockcroft-Gault formula]
- •9.Any serious medical condition (including multiorgan failure) or abnormality of clinical laboratory tests that, in the investigatorââ?¬•s judgment, precludes the patient safe participation in and completion of the study.
- •10.Absolute Neutrophil count < 1000, platelet count < 100,000 per microliter at screening/baseline
- •11.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times upper limit of normal detected at screening/baseline
- •12.Participating in other drug clinical trials
- •13.Pregnant or breastfeeding or positive pregnancy test in a pre-dose examination
- •14.History or known case of Hepatitis B, C or HIV
- •15.Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.
研究者
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