Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by proportion of patients with presence of antibodies titres compared with the control group.
研究概览
简要总结
COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), had caused widespread impact on health, including substantial mortality among those with pre-existing health conditions including cirrhosis. Patients with liver cirrhosis are at increased risk of severe disease and death from the virus infection that causes COVID-19 and are therefore a priority for immunization, should an efficacious vaccine be developed. Currently, there are no specific treatments available against COVID-19 and cirrhosis patients are a priority group for vaccination.
详细描述
- Study population: Group 1: Liver Cirrhosis Group 2: Control Group (Healthy controls)
- Study design: A Single Centre, Pilot Study,Adaptive Clinical Trial
- Study period: 1 year, Enrolment Period: Mar 2021 to Aug 2021
- Sample size with justification:
Study is being conducted as a pilot study. First 100 participants will be enrolled in both the groups. However a preliminary analysis will be done after enrollment of 50 participants in each group. Study is being conducted as a Adaptive Clinical Trial.
- Intervention:
2 IM doses (0.5 mL) of AZD1222(Covishield) at Day 0 and after 6-8 weeks of first dose (Day 42-56 days). This schedule will be followed for the first 100 participants, following which vaccination schedule as per the prevailing Government protocols shall be followed as a part of Adaptive Clinical Trial.
- Monitoring and assessment:
SARS CoV2 serum IgG Levels and neutralizing antibody titers:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following patients will be enrolled in the study under Group 1:
- •Age greater than and equal to 18 years
- •Evidence of liver cirrhosis established during the clinical investigations and/or hospital stay, as evidenced by clinical, endoscopic, radiological and/or histological criteria.
- •Baseline Negative SARS-COV19 IgG neutralizing antibodies
- •The following patients (healthy controls) will be enrolled in the study:
- •Age greater than and equal to 18 years
- •Baseline Negative SARS-COV19 IgG neutralizing antibodies
- •No previous COVID-19 infection
- •No major respiratory, cardiac comorbid illnesses or malignancy or immunosuppressed state
排除标准
- •Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
- •Prior or concomitant vaccine therapy for COVID-19
- •ICU patients
- •Hemodynamically unstable patients, shock
- •Significant encephalopathy, acute kidney injury
- •Documented or suspected sepsis including chest infection
- •ACLF (Acute on Chronic Liver Failure)
- •Significant cardiac or respiratory co-morbidities
- •Known allergy to vaccination
- •Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
- •History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 (Covishield) vaccine.
- •Any history of angioedema.
- •Any history of anaphylaxis.
- •Pregnancy, lactation or willingness/intention to become pregnant during the study.
- •Any other serious chronic illness requiring hospital specialist supervision.
- •Currently or in last 3 weeks have: fever/cough/sorethroat/rhinorrhea/hemoptysis/breathlessness/chest pain/myalgia/nausea/vomiting/diarrhea/abdominal pain/loss of taste
结局指标
主要结局
To evaluate the efficacy of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by proportion of patients with presence of antibodies titres compared with the control group.
时间窗: 6 months
To evaluate the safety/tolerability of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by comparison of safety profile of AZD1222 (Covishield) in both the groups
时间窗: 6 months
Safety/tolerability will be assessed by collecting the adverse event data,events of decompensation and new onset of COVID 19 infection by RTPCR.
次要结局
- Incidence of local and systemic solicited adverse events.(Day 7 post treatment)
- Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.(Day 30 post Treatment)
- Incidence of adverse events(28 days)
- The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.(1 year)
- The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.(1 year)
- The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention.(1 year)
- Determine the rate of new SARS-CoV2 infections, including the mutant strains.(1 year)
- To study the profile of immune cells after vaccination.(1 year)
- To study the profile of cytokine signatures after vaccination.(1 year)
- To determine the clinical severity of new SARS-CoV2 infections, including that of mutant strains.(1 year)