Review: Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial

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Review: Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial

Review: Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial

This randomized clinical trial showed that convalescent plasma therapy + standard treatment did not improve time to clinic improvement within 28 days compared to standard treatment alone in patients with severe or life-threatening COVID-19. 

  • Patients were recruited from 7 medical centers in China. The study recruitment was from February 14, 2020, to April 1, 2020. Follow-up was completed on April 28, 2020.
  • Severe COVID-19 was defined as respiratory distress (≥30 breaths/min; in resting state, oxygen saturation of 93% or less on room air; or arterial partial pressure of oxygen (Pao2)/fraction of inspired oxygen (FiO2) of 300 or less. Life-threatening COVID-19 was defined as respiratory failure requiring mechanical ventilation; shock; or non-lung organ failure requiring intensive care unit (ICU) monitoring.
  • Standard treatment consisted of symptomatic control and supportive care for COVID-19 and may have included other antiviral, antibacterial, IVIG, steroids, herbal medications
  • The primary outcome was time to clinical improvement within a 28-day period. Clinical improvement was defined as patient discharge OR reduction of 2 points on a 6-point disease severity scale.
  • The authors reported that the COVID-19 outbreak in China was being contail and thus they weren’t able to reach its targeted original sample size of 200 patients; only 103 were enrolled
  • Severe COVID-19 group: 23 patients in the convalescent plasma group and 22 patients in the control group
  • Life-threatening COVID-19 group: 29 patients in the convalescent plasma group and 29 patients in the control group
  • Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03)
  • Among those with life-threatening disease, the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17)
  • While there was a signal of possible clinical benefit for convalescent plasma among patients with severe COVID-19, because the test for interaction by disease severity was not statistically significant, the findings for the severe and life-threatening subgroups should not be interpreted as different
  • 2 participants reported transfusion-related adverse events following convalescent plasma transfusion.
|2020-06-04T09:41:06-04:00June 3rd, 2020|COVID-19 Literature|0 Comments

About the Author: Megan McHenry

Megan McHenry
Megan S. McHenry, MD, MS, FAAP is a pediatrician and an Assistant Professor of Pediatrics in the Ryan White Center for Pediatric Infectious Disease and Global Health at Indiana University School of Medicine. Dr. McHenry's research focuses on early childhood development in children living in resource-limited settings. This work is frequently aligned with community-engaged research and dissemination and implementation science frameworks. She primarily conducts research in collaboration with the Academic Model for Providing Access to Healthcare (AMPATH) Research Network in Kenya. Dr. McHenry currently has a career development award through the National Institutes of Health to develop a neurodevelopmental screening program for children born to HIV-infected mothers in Kenya. Dr. McHenry is also the Director of Pediatric Global Health Education and a co-Director of the Morris Green Physician-Scientist Development Program at Indiana University School of Medicine. In additional to global health lectures, she also educates residents and students on early childhood development, basic biostatistical techniques, research methodologies, and research ethics. She mentors multiple pediatric fellows, residents, and medical students interested in early childhood development within global contexts.

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