Clinical trial to Compare effects and safety of Etanercept in Patients with Moderate COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/04/032531
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. 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 Ã? 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
1. 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 Ã? ULN o Creatinine >1.5 Ã? ULN
3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
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
5. Known case of hepatitis B, hepatitis C or HIV infection.
6. 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 â?¥2 points reduction on WHO Ordinal Scale)Timepoint: Day 14
- Secondary Outcome Measures
Name Time Method All cause mortalityTimepoint: complete;Change in levels of biomarkers (D-dimer, C-reactive protein, IL-6, ferritin, TNF)Timepoint: Day 4, 7 and 14;Duration of hospitalizationTimepoint: complete;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) including secondary bacterial infectionTimepoint: Day 14;Proportion of patients requiring mechanical ventilationTimepoint: Day 14;Proportion of patients with clinical improvement (defined as â?¥2 points reduction on WHO Ordinal Scale)Timepoint: Day 7;Proportion of patients with clinically significant reduction in biomarkers: D-dimer, CRP, IL-6, ferritin, TNF.Timepoint: Day 4, 7 and 14 from baseline;Safety endpoints: Proportion of patients experiencing Treatment-Emergent Adverse EventsTimepoint: Day 14;Time to clinical improvement measured using WHO Ordinal Scale (defined as â?¥2 points improvement)Timepoint: Day 14;Time to clinical recoveryTimepoint: Day 14