CTRI/2022/08/044713尚未招募2 期
Efficacy and safety of ES16001 in patients with COVID-19: a phase II/III, multinational, randomized, parallel-group, double-blind, placebo-controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Those with full understanding of the clinical study and agreeing in the participation of the clinical study voluntarily in writing, or with a deputy granted with legal authority of the relevant patient if he/she is unable to agree with the clinical study in person
- •2.Adults aged 18 or above at the time of screening (according to the legal age for adult in each country
- •3.Diagnosis of COVID-19 including a positive RT-PCR for SARS-CoV-2 within 3 days prior to administering the IMP
- •4.Mild or moderate patients who have the following conditions at screening and confirm at randomization:
- •A.Mild: Those with COVID-19 symptoms relevant to the inclusion criteria 5 without breathing difficulty or other chest radiation examination
- •B.Moderate: Those with disease in respiratory organs in the clinical evaluation or imaging examination (chest radiation examination, etc.) and also relevant to the following conditions:
- •Higher than 94% of oxygen saturation (SpO2) with room air at screening and confirm at randomization
- •Lower than 30 times/min respitatory frequency at screening
- •5.Those who happen more than one of the following symptoms within 3 days prior to the treatment of IMP and also have more than one of symptoms within a day prior to the treatment of IMP
- •3.Shortness of breath
- •5.Muscle painââ?¬•
- •6.Headache
- •7.Sore throat
- •8.Loss of smell/taste
- •9.Nasal congestion
- •10.Runny nose
- •11.Fatigue
- •12.Nausea and vomiting
- •13.Diarrhea
- •6.Those being hospitalized or scheduled in hospital or quarantined facilities
- •7.Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide
排除标准
- •1.Those with known or suspected hypersensitivity to ES16001 or any of its excipients
- •2.Those with genetic issues with galactose intolerance, lapp lactase deficiency, or glucose-galactose malasorption, etc
- •3.Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for Torsades de pointes (TdP) (hypokalemia, hypomagnesemia or hypocalcemia, family history of long QT syndrome, low left ventricular ejection fraction, left ventricular hypertrophy, ischemia and slow heart rate)
- •4.Concomitant use of hydroxychloroquine or other drugs known to prolong QT interval throughout the study
- •5.Suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- •6.Immunosuppressor or immunomodulatory drugs within the past 3 months (excluding corticosteroids) and patients with autoimmune disease
- •7.Patients with one of the following severe COVID-19 signs at randomization (based on NIH classification)
- •SpO2 <94% of oxygen saturation without oxygen supply in room air
- •PaO2/FiO2 <300 mmHg
- •Respiratory frequency >30 times/min
- •Parenchyma infiltration > 50%
- •8.Patients requiring oxygen treatment (nasal prong, facial mask, and high flow oxygen) or machine respiration (oxygen by NIV or high flow, intubation and mechanical ventilation, and etc.) at randomization
- •9.Those requiring ECMO or CRRT treatment due to damage on multiple organs with severe illness (respiratory failure, shock, or multiple organ disorder)
- •10.Those with issues on kidney or liver as follows in the screening
- •1) ALT or AST > 5 x upper limit of normal (ULN) at screening
- •2)Total bilirubin that is 1.5 x upper limit of normal (ULN) at screening in the blood
- •3) Serum creatine > 2mg/dL ( > 176.8 Ã?¼mol/L) or estimated creatine clearance < 30ml/min measured or calculated by Cockroft Gault equation 11. ANC <1000/Ã?µL in the screening
- •11.platelet count <50,000/Ã?µL in the screening
- •12.Those who are pregnant or breastfeeding
- •13.Treatment with an investigational product within 5 times half-life or to 30 days from the screening (whichever is longer)
- •14.Those taking antiviral drugs, anti-inflammatory medicine, or neutralizing antibody that is known to influence the treatment of COVID-19 (refer to 7.4.2 Prohibited mendication)
- •Those with chronic disease that is inappropriate for the participation in clinical study judged by the investigator (Uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease, chronic cardiovascular disease, blood cancer, chemotherapeutic cancer patients, patients taking immunosuppressants, idiopathic thrombocytopenia, hyperkalemia patients, etc.)
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