BACKGROUND AND PURPOSE:

• Li et al. (JAMA, 2020) examined the efficacy and adverse effects of convalescent plasma therapy plus standard treatment, compared with standard treatment alone, for patients with severe or life-threatening COVID-19

METHODS:

• Open-label, multicenter, randomized clinical trial (RCT)
• Setting
  • 7 medical centers in Wuhan, China
  • February 14, 2020, to April 1, 2020
• Participants
  • RT-PCR confirmed COVID-19 with either
    • Severe: Respiratory distress and/or hypoxemia or
    • Life-threatening: Shock, organ failure, or requiring mechanical ventilation
• Intervention
  • Convalescent plasma in addition to standard treatment
  • Standard treatment alone
• Study design
  • Randomization stratified based on the severity of COVID-19 (severe or life-threatening)
  • The trial was terminated early: No new cases were reported for 7 consecutive days after March 24
  • Time to clinical improvement was defined as either
    • Patient discharged alive
    • Reduction of 2 points on a 6-point disease severity scale which ranged from 1 (discharge) to 6 (death)
• Primary outcome
  • Time to clinical improvement within 28 days
• Secondary outcome
  • 28-day mortality
  • Time to discharge
  • Rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours

RESULTS:

• 103 patients (study planned for 200)
  • Median age: 70 years
  • Convalescent plasma: 52 patients
  • Standard care: 51 patients
• No significant difference in clinical improvement seen within 28 days between the groups (P = 0.26)
  • Convalescent plasma: 51.9%
  • Standard care: 43.1%
  • Difference 8.8% (95% CI, −10.4% to 28.0%)
  • Hazard ratio (HR) 1.40 (95% CI, 0.79 to 2.49)
• Patients with severe disease: Clinical improvement within 28 days occurred more frequently in the convalescent plasma group (P=0.03)
  • Convalescent plasma: 91.3%
  • Standard care: 68.2%
  • HR 2.15 (95% CI, 1.07 to 4.32)
• Patients with life-threatening disease: No significant difference in the incidence of clinical improvement within 28 days between the groups (P=0.83)
  • Convalescent plasma: 20.7%
  • Standard care: 24.1%
  • HR 0.88 (95% CI, 0.30 to 2.63)
• There was no significant difference in
  • 28-day mortality
  • Time from randomization to discharge by day 28
• Convalescent plasma treatment was associated with a higher positive to negative viral PCR conversion rate at 72 hours
  • Convalescent plasma: 87.2% (P<0.001)
  • Standard care: 37.5%
  • OR 11.39 (95% CI, 3.91 to 33.18)
• Adverse events
  • Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care

CONCLUSION:

• For patients with severe or life-threatening COVID-19, convalescent plasma therapy plus standard care was not associated with a decreased in time to clinical improvement
• The authors note that due to early termination of the trial, the study may have been underpowered

Learn More – Primary Sources:

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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