Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-Threatening COVID-19 - Convalescent Plasma for COVID-19

Jun 08, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Chinese Academy of Medical Sciences
Date Published:
06/03/2020
Date Updated:
06/08/2020
Original Posted Date:
06/08/2020
References

Contribution To Literature:

The trial failed to show that convalescent plasma was superior to standard therapy on time to clinical improvement.

Description:

The goal of the trial was to evaluate convalescent plasma compared with standard therapy among participants with severe or life-threatening coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomized
  • Parallel

Participants with severe or life-threatening COVID-19 infection were randomized to convalescent plasma (n = 52) versus standard therapy (n = 51).

  • Total number of enrollees: 103
  • Duration of follow-up: 28 days
  • Mean patient age: 70 years
  • Percentage female: 48%
  • Percentage with diabetes: 17%

Inclusion criteria:

  • Patients ≥18 years of age with severe or life-threatening COVID-19 infection. Severe infection was defined as respiratory distress and/or hypoxemia, while life-threatening was defined as shock, organ failure, or requiring mechanical ventilation.
  • Polymerase chain reaction (PCR)-confirmed diagnosis of COVID-19 infection
  • Hospital admission with pneumonia

Exclusion criteria:

  • Pregnancy or lactation
  • Immunoglobulin (Ig) allergy
  • IgA deficiency
  • Pre-existing comorbidity that could increase the risk of thrombosis
  • Life expectancy <24 hours
  • Disseminated intravascular coagulation
  • Severe septic shock
  • Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <100
  • Severe congestive heart failure
  • Detection of high titer of S protein

Principal Findings:

The primary outcome, clinical improvement within 28 days, occurred in 51.9% of the convalescent plasma group compared with 43.1% of the standard care group (p = 0.26).

Among those with severe disease, the primary outcome occurred in 91.3% of the convalescent plasma group compared with 68.2% of the standard care group (p = 0.03).

Among those with life-threatening disease, the primary outcome occurred in 20.7% of the convalescent plasma group compared with 24.1% of the standard care group (p = 0.83; p for interaction = 0.17).

Secondary outcomes:

  • Mortality at 28 days: 15.7% in the convalescent plasma group compared with 24.0% of the standard care group (p = 0.30)
  • Negative conversion rate of viral PCR at 72 hours: 87.2% in the convalescent plasma group compared with 37.5% of the standard care group (p < 0.001)

Interpretation:

Among participants with COVID-19 infection, convalescent plasma was not superior to standard therapy on time to clinical improvement. Mortality at 28 days was similar between treatment groups. The trial was terminated early due to containment of the virus in Wuhan, China.

References:

Li L, Zhang W, Hu Y, et al. 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;Jun 3:[Epub ahead of print].

Editorial: Casadevall A, Joyner MJ, Pirofski LA, et al. A Randomized Trial of Convalescent Plasma for COVID-19—Potentially Hopeful Signals. JAMA 2020;Jun 3:[Epub ahead of print].

Clinical Topics: COVID-19 Hub, Diabetes and Cardiometabolic Disease, Prevention

Keywords: Convalescence, Coronavirus, COVID-19, Cross Infection, Plasma, Pneumonia, Polymerase Chain Reaction, Respiration, Artificial, Respiratory Distress Syndrome, Secondary Prevention, severe acute respiratory syndrome coronavirus 2, Shock, Septic


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