An observational study in Covid19, sponsored by Kufa University. Completed at 2 sites in Iraq. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Kufa University · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 400 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Kufa University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Hospitalized patients diagnosed with COVID-19
Exclusion Criteria:
Time to clinical improvement
modified six-point ordinal scale of COVID-19
Time frame: 14 days
Find the prediction factors associated with good outcome of patients on CP therapy
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
Time frame: 14 days
Time to negative PCR
number of days required for patients to be have negative PCR (free viral load)
Time frame: 14 days
Mortality rate
number of deaths
Time frame: 21 days
Hospital stay time
duration of stay in hospital
Time frame: 21 days
Adverse effect of plasma therapy
to asses the frequency of adverse effect of convalescent plasma
Time frame: 21 days
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Kufa University