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临床试验/NCT04764747
NCT04764747已完成不适用

Evaluating Effectiveness of Convalescent Plasma and Factors Influencing Therapeutic Outcome in Hospitalized Patients With COVID-19

Kufa University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Time to clinical improvement

研究概览

简要总结

Multicenter retrospective cohort study from June to August 2020 on hospitalized COVID-19 patients admitted to Al-Hakeem and Al-Amal hospital in Al-Najaf Governorate, Iraq, in order to evaluating the effectiveness of plasma therapy in hospitalized patients with COVID-19 and analyzing factors that affect therapeutic outcome, either related to patients or related to donors.

详细描述

Coronavirus Disease 2019 (COVID-19) is a contagious disease with high rate of fatality caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). In Wuhan, the capital of China's Hubei province, the disease was first detected in December 2019 and has since spread globally, resulting in the continuing 2019 and 2020 coronavirus pandemic. The World Health Organization (WHO) has proclaimed that on 30 January 2020, the outbreak will be a public health emergency of international concern and will be known as a pandemic on 11 March 2020. To date, no unique antiviral therapy or effective disease-containing vaccine exists. Therefore, it is an urgent need to look for an alternative strategy for COVID-19 treatment, especially among severe patients. For more than a century, convalescent plasma (CP) therapy, a classic adaptive immunotherapy, has been used to prevent and treat many infectious diseases. CP therapy has been successfully used in the treatment of severe acute respiratory syndrome (SARS), Middle east respiratory syndrome (MERS), and the 2009 H1N1 pandemic with adequate effectiveness and protection over the past two decades. For patients with serious or life-threatening COVID-19, the US Food and Drug Administration (FDA) recently approved the emerging use of convalescent plasma. While the use of convalescent plasma looks promising, there is still little evidence supporting its use in the treatment of COVID-19 and its use is therefore still investigational.

Also, there is lack of standardization and evidence-based rationale in donor eligibility requirements account for factors such as age, sex, weight, symptom course, antibody titer and it is association with clinical outcome. Additionally, recipient related factors including age, sex, weight, disease severity, time of CP use and concomitant treatment must be considered in prediction the response to CP therapy and this may help to explain the varied therapeutic effects of CP seen in a variety of studies. Considering the above-mentioned facts and high number of patients treated with CP in AL Najaf-Hakeem hospital and Amal hospital we designed this study to evaluate the effectiveness of CP therapy in hospitalized patients with COVID-19 and find patients and donor related factors to predicts the responders and not responders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18 years old or older.
  • COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR).
  • hospitalized adult patients with COVID-19.

排除标准

  • Patients with history of alleragy to plasma transfusion.
  • Patients with history of autoimmune disease or selective IgA deficiency.
  • Patients with suspected coronavirus.
  • Patients with incomplete data in his record.

结局指标

主要结局

Time to clinical improvement

时间窗: 14 days

modified six-point ordinal scale of COVID-19

Time to negative PCR

时间窗: 14 days

number of days required for patients to be have negative PCR (free viral load)

Find the prediction factors associated with good outcome of patients on CP therapy

时间窗: 14 days

Demographic data and clinical parameters of patients associated with positive therapeutic outcome for CP measured as number of patients discharge from hospital with complete recovery (negative PCR for COVID-19). The association determined by univariate and multivariate analysis

次要结局

  • Hospital stay time(21 days)
  • Adverse effect of plasma therapy(21 days)
  • Mortality rate(21 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zainab Hadi Ibadi

Ms.Ph. Zainab Hadi Ibadi

Kufa University

研究点 (2)

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