Effectiveness of Convalescent Plasma in Hospitalized Patients With COVID-19

Completed

• Conditions: Covid19

• Registration Number: NCT04764747
• Lead Sponsor: Kufa University

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Primary Completion: 2021-04-25
• Study Completion: 2021-04-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement	14 days	modified six-point ordinal scale of COVID-19
Time to negative PCR	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	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

Secondary Outcome Measures

Name	Time	Method
Hospital stay time	21 days	duration of stay in hospital
Adverse effect of plasma therapy	21 days	to asses the frequency of adverse effect of convalescent plasma
Mortality rate	21 days	number of deaths

Trial Locations

Locations (2)

Al-Amal Hospital; 🇮🇶 Najaf, Iraq

Al-Hakeem Hospital; 🇮🇶 Najaf, Iraq