Efficacy of Convalescent Plasma Therapy in Patients With COVID-19: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier)
研究概览
简要总结
Currently, no effective treatments are available for the COVID-19. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID-19 patients. Investigator have recently concluded a pilot phase II open-label RCT on the efficacy of convalescent plasma in severe COVID 19 patients in which encouraging results were seen. Investigator plan to further study the efficacy and safety of convalescent plasma in COVID-19 severely sick patients through an RCT. Investigator will collect up to 500 ml Convalescent Plasma from the COVID-19 recovered persons after 14 days of clinical recovery with two consecutive SARS CoV-2 negative tests by PCR at least 24 hours apart. This plasma will be tested and frozen and stored. On requisition it will be thawed and sent to the treating center. Two doses of 250 ml convalescent plasma each will be transfused on two consecutive days to patients who fit the eligibility criteria (Severely sick COVID-19 patients) and are randomized to the convalescent plasma group along with the standard of care and the other group will receive standard of care alone. Data will be collected to study the benefits and adverse events related to convalescent plasma transfusion.
详细描述
Study Centres:
Institute of Liver and Biliary Sciences Sector D-1, Vasant Kunj New Delhi -110070
- Collection and testing of Convalescent Plasma
Treatment Centres
Lok Nayak Jai Prakash Hospital (LNJP)
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
- •Patients on ventilator (in last 24 hours)
- •Respiratory distress, RR ≥30 beats/min
- •Oxygen saturation level less than 90 % in resting state
- •Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg
- •Lung infiltrates > 50% within 24 to 48 hours
排除标准
- •Patient/ family members who do not give consent to participate in the study.
- •Patients with age less than 18 years
- •Patients presenting with multi-organ failure
- •Pregnancy
- •Individuals with HIV and Viral Hepatitis and Cancer
- •Extremely moribund patients with an expected life expectancy of less than 24 hours
- •Hemodynamic instability requiring vasopressors
- •Previous history of allergy to plasma
- •Cirrhosis
- •Severe renal impairment with GFR< 30ml/min or recipients of RRT, peritoneal dialysis
- •Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable Angina
- •Donor Inclusion Criteria for Plasmapheresis
- •Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days.
- •Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart.
- •Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- •Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.
- •Donors Exclusion Criteria:
- •Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under
- •the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- •Females who have been pregnant and have not been tested for HLA antibodies or are HLA antibody positive if tested and previously transfused donors (to prevent TRALI)
- •Donors who have taken steroids during treatment for COVID-19
结局指标
主要结局
Efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier)
时间窗: Day 28
The six-point scale is as follows: 1. death=6; 2. hospital admission for extracorporeal membrane oxygenation or mechanical ventilation=5; 3. hospital admission for non-invasive ventilation or high-flow oxygen therapy=4; 4. hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation)=3; 5. hospital admission but not requiring oxygen therapy=2; 6. discharged or having reached discharge criteria (defined as clinical recovery-ie, normalization of pyrexia, respiratory rate 94% on room air, and relief of cough, all maintained for at least 72 h)=1.
次要结局
- Mortality in both groups(Day 28)
- Presence of antibodies against SARS-CoV-2 in serum after plasma administration(Day 14)
- Correlation of the titers in COVID-19 convalescent plasma donors with duration of illness, the severity of symptoms, duration of hospital stay, drugs used in therapy, duration between recovery, and donation.(Day 28)
- Proportion of patients in each category according to the ordinal scale(Day 28)
- Duration of oxygen therapy in both groups(Day 28)
- Duration of hospital stay in both groups(Day 28)
- Proportion of patients on mechanical ventilation at day 7 in both groups(Day 7)
- Duration of Intensive Care Unit stay(Day 28)
- Incidence of adverse effects in both groups(Day 28)
- Change in Cytokines in both groups(Day 28)
- Change in acute phase reactants in both groups(Day 28)