Clinical trial NCT04764747: Effectiveness of Convalescent Plasma in Hospitalized Patients With COVID-19
Official title: Evaluating Effectiveness of Convalescent Plasma and Factors Influencing Therapeutic Outcome in Hospitalized Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients diagnosed with COVID-19

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to clinical improvement
timeFrame: 14 days
measure: Find the prediction factors associated with good outcome of patients on CP therapy
timeFrame: 14 days
measure: Time to negative PCR
timeFrame: 14 days
Secondary outcomes:
measure: Mortality rate
timeFrame: 21 days
measure: Hospital stay time
timeFrame: 21 days
measure: Adverse effect of plasma therapy
timeFrame: 21 days
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: Al-Amal Hospital
city: Najaf
country: Iraq
facility: Al-Hakeem Hospital
Study officials:
References:
citation: Chauhan S. Comprehensive review of coronavirus disease 2019 (COVID-19). Biomed J. 2020 Aug;43(4):334-340. doi: 10.1016/j.bj.2020.05.023. Epub 2020 Jun 1.
citation: Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
citation: Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
citation: Farhat RM, Mousa MA, Daas EJ, Glassberg MK. Treatment of COVID-19: Perspective on Convalescent Plasma Transfusion. Front Med (Lausanne). 2020 Jul 28;7:435. doi: 10.3389/fmed.2020.00435. eCollection 2020.