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.
