COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43485

Kuldeep K Chauhan

pooja.sharma@medanta.org

2020-05-27

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

I. Male or female subjects who are â?¥18 years of age, on the day of signing informed consent. <br/ >II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure. <br/ >III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen, e.g., respiratory, blood, urine, stool, other bodily fluid). <br/ >IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%-94%, and severe disease - respiratory rate â?¥ 30/minute and/or SpO2 < 90% on room air, or ARDS or Septic shock <br/ >

I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ >II. Active tuberculosis (TB) infection. <br/ >III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ >IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ >V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ >VI. Participating in other drug clinical trials <br/ >VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ >X. Definite diagnosis of rheumatic immune related diseases. <br/ >XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ >XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ >XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ >

2

Medanta Institute of Education and Research MIER

18

85

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

180

Proportion of subjects showing progressive COVID 19 disease from moderate to severe; or from severe disease to deathTimepoint: Up to Day 14

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

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]