A prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety and tolerability of 101-PGC-005 (‘005) for the treatment of moderate COrona VIrus Disease (Covid-19) disease patients.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 268
- 试验地点
- 11
- 主要终点
- Clinical improvement or shift in WHO 11-point ordinal scale rating
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.
COVID-19 disease does not have any approved treatment. However, an array of drugs approved for other indications, as well as multiple investigational agents, are being studied for the treatment of COVID-19 in several hundred clinical trials around the globe. The recent RECOVERY Trial demonstrated the success of dexamethasone in treating late stage COVID-19 patients. However, use of Dexamethasone increased mortality in early stage of the disease and due to limitations of use of free dexamethasone because of the dose and duration that is insufficient to properly treat COVID-19 patients. As majority of the cells have glucocorticoid receptors to which the dexamethasone binds, highly toxic dose would be needed to effectively treat . COVID-19 disease which would result in increase in mortality and this dose may modulate T cells and other immune cells, resulting in decreased natural immunity. 101- PGC-005 (‘005), which is a prodrug of dexamethasone will address the many safety issues limiting this most powerful anti-inflammatory agent.
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety and tolerability of 101-PGC-005 (‘005) when used alongside Standard of Care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of age 18 to 65 years (both inclusive) who have been hospitalized for treatment of moderate COVID-19 disease.
- •Patients with moderate COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization a.
- •Fever, cough, with or without sore throat, throat irritation, body ache, headache, malaise, weakness, diarrhoea or gastrointestinal upset, with or without anorexia, nausea, vomiting, with or without loss of smell and or taste, shortness of breath, breathlessness and difficulty in breathing b.
- •Respiratory rate of 24 to 30 breaths per min, c.
- •SpO2 90 – 93 percent on room air
- •Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (first RT-PCR positive sample collected within 7 days prior to randomization)
- •Elevated CRP, ESR or Ferritin levels
- •In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy.
- •Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures.
- •In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR).
排除标准
- •Patients with mild or severe COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI at the time of randomization.
- •This includes any one or more of the following a.
- •Peripheral Blood oxygen saturation 94 percent or 90 percent b.
- •Respiratory Rate or less than 24 or more than 30 breaths per minute
- •First positive RT-PCR more than 7 days prior to treatment administration
- •Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study
- •Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR less than 30ml per min).
- •Renal dysfunction [Serum Creatinine more than 2.5 times of ULN or calculated creatinine clearance less than 30ml per min], Liver Dysfunction [Total Bilirubin more than 3 times ULN & AST, ALT more than 5 times ULN].
- •Chronic systemic glucocorticoid treatment or any immunosuppressive treatment
- •History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Pregnant and Lactating patients.
- •Patients who require IL-6 inhibitors for management of inflammation at the time of study entry.
- •Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year.
- •Hospital discharge is anticipated in less than 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours.
- •Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug or biologic) prior to randomization (whichever is longer).
结局指标
主要结局
Clinical improvement or shift in WHO 11-point ordinal scale rating
时间窗: Baseline through Day 10, Day 14 and Day 28
次要结局
- Improvement in COVID-19 Symptoms such as Fever, Heart Rate and Oxygen Saturation (SpO2(Baseline through Day 10, Day 14 and Day 28)
- Improvement biochemical inflammatory markers such as CRP, Neutrophil Lymphocyte ratio, D-Dimer, Serum Ferritin, IL-6, TNF alpha(Baseline, End of Treatment, Day 5 or Discharge, Day 10, 14 and 28)
- Requirement of auxiliary oxygen therapy(28 Days)
- Discharge Rate from hospital(28 Days)
- Rate of ICU Admission , Mechanical Ventilation(28 Days)
- Time to respiratory viral clearance(Day 3, 7, 10 and 14)
- Improvement in lung injury on Chest HRCT(Baseline, 28 Days)
- All-cause mortality(28 Days)
研究者
Kartik Sahni
Insignia Clinical Services Pvt. Ltd.