Abstract

BackgroundConvalescent 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.MethodsSingle 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.ResultsA 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%).ConclusionCP transfusion can be used as a safe and useful treatment in moderately severe and severe patients.Trial registrationThe trial registration number is NCT04352751 (https://www.irct.ir/search/result?query=IRCT20200414047072N1). Trial Registration date is 28th April 2020.

Highlights

  • Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a novel member of Coronaviridae family [1]

  • Convalescent plasma (CP) was transfused in all patients with variable titers; Median 1:320, including high titers (1: 160-1:320 U/mL) CP infusion done in 31 non- intubated subjects (62%) of severe group and 2(4%) in intubated critical

  • COVID-19 is characterized by tissue injury as a result of alveolar capillary micro thrombi more prevalent in COVID patients leading to tissue hypoxia [18] and in our dataset raised levels of non-specific tissue injury marker i.e. Lactate Dehydrogenase (LDH) was observed in patients before CP treatment which sharply reduced after CP transfusion (Table 2 [10])

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Summary

Introduction

Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a novel member of Coronaviridae family [1] It is a positive sense RNA beta-corona virus possibly evolved as a result of animal spill over from bats [2]. New antivirals like remdesivir is a promising candidate among other explored treatment options but the data on its safety and efficacy is still limited. Immune therapies such as the use of convalescent plasma (CP) for the treatment of infectious diseases SARS, MERS, Ebola, Measles, polio, H1N1 influenza etc., has been proven effective for more than a century especially during emergency situations [5]. The study aimed at appraisal of CP transfusion safety and usefulness in COVID pneumonia

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