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COVID-19 Management

Does Convalescent Plasma Therapy Reduce Time to Clinical Improvement in Patients with COVID-19?

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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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Related ObG Topics:

More Evidence Suggesting Convalescent Plasma Therapy May Be Effective in Patients with Severe COVID-19
Use of Convalescent Plasma in Critically Ill COVID-19 Patients: Results from a Preliminary Study
ACTT-1 Remdesivir RCT: Preliminary Results Now Published

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