Clinical trial to Compare effects and safety of Etanercept in Patients with Moderate COVID-19

Phase 2

Recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/04/032531
• Lead Sponsor: Lupin Limited

Brief Summary

This is a Phase II, multi-centre, double blind, randomized, comparative study designed to evaluate efficacy and safety of etanercept as an add-on therapy to Remdesivir in moderate COVID-19 patients. Approximately 50 patients are planned to be enrolled in the trial. Etanercept is already approved in India for treatment of several auto-immune and inflammatory disorders. The efficacy and safety of Etanercept in COVID-19 is not yet established. Therefore, this study is designed to explore efficacy and safety of Etanercept in moderate COVID-19 patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-31
• Study Start: 2021-12-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or female patients 18-65 years of age or older 2.
• Willing and able to provide written informed consent prior to performing study procedures 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 4.
• Have indicators of risk of progression: at least 1 inflammatory marker (e.g. D-dimer, IL6, CRP, ferritin, TNF) ≥2 × upper limit of normal (ULN) 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.

Exclusion Criteria

• Require invasive mechanical ventilation 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 × ULN o Creatinine >1.5 × ULN 3.
• Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
• 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 5.
• Known case of hepatitis B, hepatitis C or HIV infection.
• Known hypersensitivity to etanercept or any component of the formulation 7.
• Patients having received Remdesivir prior to screening 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 9.
• Participation in any other clinical trial of an experimental treatment for COVID-19 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with clinical improvement (defined as ≥2 points reduction on WHO Ordinal Scale)	Day 14

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with clinically significant reduction in biomarkers: D-dimer, CRP, IL-6, ferritin, TNF.	Day 4, 7 and 14 from baseline
Change in levels of biomarkers (D-dimer, C-reactive protein, IL-6, ferritin, TNF)	Day 4, 7 and 14
Duration of hospitalization	complete
Time to clinical improvement measured using WHO Ordinal Scale (defined as ≥2 points improvement)	Day 14
Safety endpoints: Proportion of patients experiencing Treatment-Emergent Adverse Events	Day 14
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) including secondary bacterial infection	Day 14
Proportion of patients with clinical improvement (defined as ≥2 points reduction on WHO Ordinal Scale)	Day 7
Time to clinical recovery	Day 14
Proportion of patients requiring mechanical ventilation	Day 14
All cause mortality	complete

Trial Locations

Locations (7)

Ashirwad Hospital & Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Gunjkar Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Karnataka Institute of Medical Sciences; 🇮🇳 Dharwad, KARNATAKA, India

Max Smart Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

St Georges Hospital Grant Government Medical College & Sir JJ Group of Hospitals, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Vinaya Hospital and Research Centre; 🇮🇳 Kannada, KARNATAKA, India

Ashirwad Hospital & Research Centre

🇮🇳Thane, MAHARASHTRA, India

Dr Shrikant Deshpande

Principal investigator

9822017445

writetoshrikant@rediffmail.com