Study to Assess the Efficacy and Safety of BP08 (Tocilizumab) versus Actemra�®/RoActemra�® plus Standard of Care in Severe COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036973
- Lead Sponsor
- CURATEQ BIOLOGICS PRIVATE LIMITED India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 � 75mg/L.
o IL-6 � 40 pg/mL
6.Informed consent for participation in the study either by Patient or LAR
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method