Usefulness of convalescent plasma transfusion for the treatment of severely ill COVID-19 patients in Pakistan

Tehmina Nafees Sonia Khan, Samina Naz Mukry, Shahtaj Masood, Lubna Meraj, Bikha Ram Devrajani, Javed Akram, Naveena Fatima, Sidra Maqsood, Ayesha Mahesar, Roomana Siddiqui, Sadia Ishaque, Muhammad Bilal Afzal, Sanam Mukhtar, Sara Ahmed, Arshi Naz, Tahir Sultan Shamsi, Tehmina Nafees Sonia Khan, Samina Naz Mukry, Shahtaj Masood, Lubna Meraj, Bikha Ram Devrajani, Javed Akram, Naveena Fatima, Sidra Maqsood, Ayesha Mahesar, Roomana Siddiqui, Sadia Ishaque, Muhammad Bilal Afzal, Sanam Mukhtar, Sara Ahmed, Arshi Naz, Tahir Sultan Shamsi

Abstract

Background: Convalescent plasma(CP) was utilized as potential therapy during COVID-19 pandemic in Pakistan. The study aimed at appraisal of CP transfusion safety and usefulness in COVID pneumonia.

Methods: Single arm, MEURI study design of non-randomized open label trial was conducted in five centers. Patients werecategorized as moderately severe, severe, and critical. The primary endpoint was a) improvement in clinical status and change in category of disease severity; secondary endpoint was b) CP ability to halt disease progression to invasive ventilation. CP transfused to hospitalized patients. Statistical tests including median (interquartile ranges), Mann-Whitney U test, Fisher's exact test using SPSS ver. 23, ANOVA and Chi-square test were applied for the analysis of results parameters before and after CP treatment. SOFA score was applied for multiorgan failure in severe and critical cases.

Results: A total of 50 adult patients; median age 58.5 years (range: 29-92 years) received CP with infusion titers; median 1:320 U/mL (Interquartile range 1:80-1:320) between April 4 to May 5, 2020. The median time from onset of symptoms to enrollment in trial was 3 to 7 days with shortness of breath and lung infiltration as severity criterion. In 35 (70%) recipients, oxygen saturation improved from 80 to 95% within 72h, with resolution of lung infiltrates. Primary endpoint was achieved in 44 (88%) recipients whereas secondary endpoint was achieved in 42 (84%). No patient experienced severe adverse events. A high SOFA score (> 7) correlated with deaths in severe and critical patients. Eight (16%) patients expired due to comorbidities; cardiac arrest in 2 (4%), multiorgan failure secondary to cytokine storm in 5 (10%) and ventilator associated complications in 1 (2%).

Conclusion: CP transfusion can be used as a safe and useful treatment in moderately severe and severe patients.

Trial registration: The trial registration number is NCT04352751 ( https://www.irct.ir/search/result?query=IRCT20200414047072N1 ). Trial Registration date is 28th April 2020.

Keywords: COVID-19; Convalescent CP recipient; Convalescent plasma (CP); SARS CoV2 infection; SOFA score.

Conflict of interest statement

There are no conflict of interest to disclose.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The country plan for Passive immunization explains the entire process from submission of protocol for approval to site management, data sharing and monitoring of entire trial process in all authorized centers of transfusion across Pakistan
Fig. 2
Fig. 2
Manifests the initial response as decline in raised values of Respiratory rate, CRP, ferritin, and increased Oxygen saturation after CP administration in first 72 h
Fig. 3
Fig. 3
Radiological findings on chest X-ray of COVID-19 positive patient. A Pre-CP findings exhibits patchy infiltrations bilaterally. B Post CP CXR shows absorption of pulmonary infiltrates and improvement bilaterally on 5th day of CP transfusion
Fig. 4
Fig. 4
Survival curve of moderate, severe, and critical COVID-19 CP recipient patients through Kaplan-Meier analysis

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