COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53930

Dr Neelakant Krishnan

chiragshah@lupin.com

2021-04-05

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female patients 18-65 years of age or older <br/ >2. Willing and able to provide written informed consent prior to performing study procedures <br/ >3. Confirmed SARS-CoV-2 infection within 10 days as determined by RT-PCR with presence of clinical features such as dyspnea and or hypoxia, fever, cough, SpO2 <94% (range 90-94%) on room air <br/ >4. Have indicators of risk of progression: at least 1 inflammatory marker (e.g. D-dimer, IL6, CRP, ferritin, TNF) â?¥2 Ã? upper limit of normal (ULN) <br/ >5. Females of childbearing potential must have a negative serum pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 3 months following last dose of study drug

1. Require invasive mechanical ventilation <br/ >2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ >3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ >5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ >6. Known hypersensitivity to etanercept or any component of the formulation <br/ >7. Patients having received Remdesivir prior to screening <br/ >8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ >9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ >10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.

2

Lupin Limited

18

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

Proportion of patients with clinical improvement (defined as â?¥2 points reduction on WHO Ordinal Scale)Timepoint: Day 14

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

Phase 2

[{"arm_notes": "", "treatment_id": 483, "treatment_name": "Etanercept", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]