The Role of Disease Severity and Demographics in the Clinical Course of COVID-19 Patients Treated With Convalescent Plasma.

Tengfei Ma,Michael J Joyner,Andrew J Clayburn,Patrick W Johnson,Jonathon W Senefeld,Nigel S Paneth,R Scott Wright,Chad C Wiggins,Delisa Fairweather,Rickey E Carter,Sarah E Baker,Stephen A Klassen,Winston L Guo,Breanna M Kornatowski,Ra'Ed S Hailat,Chenxi Li,Katelyn A Bruno

doi:10.3389/fmed.2021.707895

Abstract

Treatment of patients with COVID-19 using convalescent plasma from recently recovered patients has been shown to be safe, but the time course of change in clinical status following plasma transfusion in relation to baseline disease severity has not yet been described. We analyzed short, descriptive daily reports of patient status in 7,180 hospitalized recipients of COVID-19 convalescent plasma in the Mayo Clinic Expanded Access Program. We assessed, from the day following transfusion, whether the patient was categorized by his or her physician as better, worse or unchanged compared to the day before, and whether, on the reporting day, the patient received mechanical ventilation, was in the ICU, had died or had been discharged. Most patients improved following transfusion, but clinical improvement was most notable in mild to moderately ill patients. Patients classified as severely ill upon enrollment improved, but not as rapidly, while patients classified as critically ill/end-stage and patients on ventilators showed worsening of disease status even after treatment with convalescent plasma. Patients age 80 and over showed little or no clinical improvement following transfusion. Clinical status at the time of convalescent plasma treatment and age appear to be the primary factors in determining the therapeutic effectiveness of COVID-19 convalescent plasma among hospitalized patients.

Highlights

The number of deaths from COVID-19 in the United States (US) had surpassed 500,000 by February 11, 2021 [1], less than a year after the first case of novel coronavirus (SARS-CoV-2) was confirmed in the US, demonstrating the urgent need to find safe and effective treatment options
Because many in the health system were overwhelmed during the time of the Expanded Access Program (EAP), we developed the Rapid Evaluation Project (REP) to be an optional reporting tool that required minimal time and effort on the part of the treating physician, but that would, provide vital information on whether improvement or worsening was noted following treatment with convalescent plasma, and how this varied by category of patient
Participants in the REP were very similar to the overall EAP population at the time of data analysis (August 1, 2020) in age distribution, sex, race and initial clinical status, but tended to have slightly more respiratory risk factors such as dyspnea, low oxygen parameters and extensive early lung infiltrates

Summary

Introduction

The number of deaths from COVID-19 in the United States (US) had surpassed 500,000 by February 11, 2021 [1], less than a year after the first case of novel coronavirus (SARS-CoV-2) was confirmed in the US, demonstrating the urgent need to find safe and effective treatment options. Analyses of the EAP so far have shown that COVID-19 convalescent plasma is safe [17, 18] and likely to be effective at treating COVID19, if antibody titers are sufficiently high [16]. Based on the clear findings in the historical convalescent plasma literature [19], we hypothesized that patients treated earlier in the course of the disease [who were not on mechanical ventilation or admitted to the intensive care unit (ICU)] or who had less severe disease at the time of transfusion would show more rapid and better improvement than convalescent plasma recipients receiving mechanical ventilation or admitted to the ICU

Methods

Results

Discussion

Conclusion