COVID-19 Management

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

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

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

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

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

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