CTRI/2020/10/028423已完成2 期
A Randomized, Open label Clinical Study to Evaluate Efficacy and Safety of PNB-001 in Patients with moderate COVID-19 Infection.
PNB Vesper Life Science Pvt Ltd2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1.Mean change in the ordinal scale from baseline.
研究概览
简要总结
This study is a A Randomized, Open label Clinical Study to Evaluate Efficacy and Safety of PNB-001 In Patients with moderate COVID-19 Infection in 40 patients in 1:1 ratio.
The Primary Endpoints are
Mean change in the ordinal scale from baseline.
Mortality Rate by Day 28
The Secondary Endpoints are
Percentage of patients showing change in clinical status using the ordinal scale from baseline.
Percent of patients showing improvement in inflammatory segments in X-ray chest from baseline.
Reduction of Days of hospitalization.
Duration of supplemental oxygen (if applicable).
Improvement in oxygen saturation from baseline.
Days to negative PCR for Covid19.
Change in (IL6, CRP) inflammatory markers from baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 aged between 18 and 65 years (both Inclusive).
- •Patients with laboratory-confirmed SARS-CoV-2 infection as determined by PCR within 2 days of randomization.
- •Patients havingPneumonia with no signs of severe disease with SpO2 ≤94% (range 90-94%) on room air.
- •Patients with any two of the following signs or symptoms suggestive of COVID-
- •dyspnoea or hypoxia.
- •Respiratory rate more or equal to 24 per minute.
- •Radiographic infiltrates as confirmed by imaging (chest xray).
- •Patients who are willing to sign written informed consent for participation in the study and willing to adhere to all protocol procedures.
- •Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
排除标准
- •Patient requiring invasive mechanical ventilation.
- •Known allergies, hypersensitivity, or intolerance to investigational product or its excipients.
- •Patients with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
- •Patients with abnormal Sr.Creatinine value of ≥ 2 mg/dl at screening visit.
- •Patients with Type 1 diabetes mellitus.
- •Patients with uncontrolled Type 2 diabetes mellitus with random sugar ≥ 200 mg/dL.
- •Uncontrolled hypertension (systolic blood pressure> 160mmHg, or diastolic blood pressure>100mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
- •History or presence of clinically significant hepatic, renal,cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, diseases or metabolic disturbances or other relevant systemic diseases that would preclude the safe administration of the Investigational product.
- •Any condition for which, in the opinion of the investigator,participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit,or confound the protocol-specified assessments.
- •History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease.
- •History of human immunodeficiency virus (HIV) antibody positive.
- •History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSMV) criteria within 1 years before Screening.
- •History of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris,myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
- •Patient received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study.
- •Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
结局指标
主要结局
1.Mean change in the ordinal scale from baseline.
时间窗: 15 Days | 28 Days
2.Mortality Rate by Day 28
时间窗: 15 Days | 28 Days
次要结局
- 1.Percentage of patients showing change in clinical status using the ordinal scale from baseline.(2.Percent of patients showing improvement in inflammatory segments in X-ray chest from baseline.)
- The assessment of safety will be based on the frequency of Adverse Events and changes in laboratory values. All safety variables will be summarized using descriptive statistics(28 Days)
研究者
研究点 (2)
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