TABLE 1.
Data related to safety of COVID‐19 convalescent plasma from randomized controlled trials and a large observational study
| Author | Study design | CCP arm N | Control arm N | Placebo used | Percentage of CCP patients with AE | Percentage of control patients with AE | Adverse events CCP within 24 h of transfusion |
|---|---|---|---|---|---|---|---|
| Li L 19 | RCT | 52 | 51 | Standard of care | 3.80% | NA | 2 with non‐severe allergic; 1 with severe TAD |
| Agarwal A 31 | RCT | 235 | 229 | Standard of care | 3.80% | NA | 1 with pain at infusion site, chills, nausea; 3 with fever and tachycardia; 2 with dyspnea and IV catheter blockage; 3 with mortality possibly related to CCP |
| Salman OH 17 | RCT | 15 | 15 | Standard of care | 0% | NA | No adverse events |
| Rasheed AM 16 | RCT | 21 | 28 | Standard of care | 4.70% | NA | 1 with mild allergic reaction |
| Simonovich VA 18 | RCT | 228 | 105 | Normal saline | 4.80% | 1.90% | 13 AE in 11 patients‐ No significant differences in the overall incidence of AE (OR, 1.21; 95% CI, 0.74–1.95) or SAE. |
| Libster R 13 | RCT | 80 | 80 | Normal saline | 0% | 0% | No adverse events |
| Joyner MJ 4 | Observational | 20,000 | NA | NA | 0.39% | NA | 78 transfusion reactions [(<1%) ‐ 36 TACO; 21 TRALI; 21 severe allergic] mortality within 4 h of transfusion: 10 reported as related to transfusion. Thrombotic or thromboembolic events: 113 (<1%) |
Abbreviations: AE, adverse events; CCP, COVID‐19 convalescent plasma; FNHTR, febrile non‐hemolytic transfusion reaction; NA, not available; OR, odds ratio; RCT, randomized controlled trial; TACO, transfusion associated circulatory overload; TAD, transfusion associated dyspnea; TRALI, transfusion‐related acute lung injury.