COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56095

Dr Shubhadeep Sinha

sreenivasa.chary@heterodrugs.com

2021-05-20

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent. <br/ >2. Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen <br/ >3. Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air. <br/ >4. Patients with elevated IL-6 ( >40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP ( >75mg/L) and ferritin 5X ULN

1. Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation. <br/ >2. Patients requiring intubation and mechanical ventilation <br/ >3. Patients with ALT/AST â?¥ 5 x upper limit of normal (ULN) <br/ >4. Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm <br/ >5. Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months <br/ >6. Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer <br/ >7. Evidence of multiorgan failure <br/ >8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >

2

Hetero Biopharma Limited

18

65

India

Severe disease at enrollment

6: Severe disease at enrollment

188

Cumulative proportion of patients requiring mechanical ventilationTimepoint: Day 14

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

Phase 3

[{"arm_notes": "Hetero-tocilizumab", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "RMP-tocilizumab", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]