Convalescent Plasma Treatment in COVID-19 Patients at a Tertiary Care Center in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Overall mortality
研究概览
简要总结
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred initially in December 2019 in the city of Wuhan, Hubei province, China. Patients mainly presented with respiratory symptoms and this novel pathogen was identified.At present, the core management of COVID-19 includes infection prevention, case detection, monitoring, and supportive care. While specific new drugs and vaccines are being researched, certain drugs that are already present in medical arsenal are under trial too.
One investigational treatment being explored for COVID-19 is the use of convalescent plasma (CP) collected from recovered COVID-19 patients. Convalescent Plasma is a source of passive immune therapy- the administration of specific antibodies against a given agent for preventing or treating an infectious disease due to that agent. The main anticipated mechanism of action of Convalescent Plasma therapy in COVID19 is viral neutralization. Other possible mechanisms include antibody-dependent cellular cytotoxicity and phagocytosis. There are numerous examples in which convalescent plasma (CP) has been used successfully as post exposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses e.g. SARS-1, MERS-CoV and very recently in 2014, the Ebola virus outbreak. In SARS-CoV-2, Shen et al published a case series of 5 critically ill patients with COVID-19 and acute respiratory distress syndrome showing improvement in clinical status after transfusion of CP.
Therefore, the objective of this study is to determine the safety and efficacy of transfusing convalescent plasma in patients admitted with COVID-19 at Aga Khan University Karachi, Pakistan. The investigators hypothesize that CP will decrease the length of hospital stay and overall mortality in patients with COVID-19.
In this study, convalescent plasma will be collected from the donors who have been recovered from SARS-CoV-2 infection and transfused it to the patients admitted with active severe /critical COVID-19 at the Aga Khan University Hospital Karachi.
STUDY DESIGN: Non-randomized open Label trial
INCLUSION CRITERIA IN TREATMENT ARM:
i. Inpatients at AKU with positive SARS-CoV-2 infection by rRT-PCR and who have provided written informed consent for inclusion in the trial;
ii. Age ≥ 18 years;
iii. Severe or immediately life-threatening COVID-19 defined by any of:
- Respiratory rate ≥ 30/min;
- Blood oxygen saturation ≤ 93% at room air;
- Partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio < 300;
- Lung infiltrates > 50% within 24 to 48 hours on radiology ( X-ray or CT scan);
- Need for mechanical ventilation.
- respiratory failure
- septic shock
- multiple organ dysfunction or failure
EXCLUSION CRITERIA:
i. Negative rRT-PCR from respiratory secretions or blood within 48 h prior to assessment of eligibility.
ii. History of allergic reaction to blood or plasma products (as judged by the investigator).
iii. Medical conditions in which receipt of 500 mL intravascular volume may be detrimental to the patient (e.g., actively decompensated congestive heart failure).
iv. Enrolment in any other clinical trial for an investigational therapy.
CONTROL GROUP:
COVID-19 patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given Standard of Care and will be followed for study outcomes. Data from these SC patients will be used as comparator in the analysis of the study.
详细描述
Objective:
To investigate the efficacy and safety of transfusing convalescent plasma collected from patients who have recovered from COVID-19 disease to patients admitted at Aga Khan University Hospital for the management of active COVID-19 disease.
Methods:
A. Study design Non-randomized open Label trial
B. Study population
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall mortality
时间窗: From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month
Status alive or death
Decrease length of stay
时间窗: From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month
Decrease length of stay in hospital , Decrease length of stay in ICU/special care unit
Incidence of adverse events related to Convalescent Plasma transfusion
时间窗: After receiving intervention (CP) till 24 hours
Any adverse event after the transfusion of Convalescent plasma which include TRALI, TACO, allergic reaction, anaphylaxis.
次要结局
- Improvement in Laboratory Parameters: Serum Ferritin(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Improvement in Laboratory Parameters: Procalcitonin(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Improvement in Laboratory Parameters: D-Dimer(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Improvement in Laboratory Parameters: Complete Blood count(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Improvement in Laboratory Parameters: C-Reactive Protein(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Ordinal scale(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
- Chest X-Ray findings(From date on which intervention given until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month)
研究者
Muhammad Hasan
Senior Instructor
Aga Khan University