Current best evidence for clinical care (more info)
BACKGROUND: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19.
METHODS: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
FINDINGS: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93-1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94-1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93-1·05; p=0·79).
INTERPRETATION: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes.
FUNDING: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
| Discipline / Specialty Area | Score |
|---|---|
| Infectious Disease | |
| Hospital Doctor/Hospitalists | |
| Internal Medicine | |
| Respirology/Pulmonology | |
| Intensivist/Critical Care | |
As a hospitalist, these findings are directly related to our line of work. It is very helpful to have evidence from a large RCT studying the use of convalescent plasma in patients hospitalized with COVID-19.
RECOVERY provides a high-quality analysis of the outcomes with convalescent plasma, essentially showing that there is no role for this in the routine treatment of COVID-19 patients. Interestingly, they essentially excluded benefit from high titer and early infection, both of which were posited to be potential benefit areas. One key subgroup not analyzed, for whom other evidence suggests a potential benefit, is immune-compromised individuals who may not mount an effective immune response. Although there may be continued need for studies in that and other highly specific subsets, this study establishes that the `standard of care` for most patients should not include convalescent plasma.
This large well-designed trial should settle any remaining doubts about the role of convalescent plasma in treating patients with COVID-19.
Probably the final dagger for convalescent plasma in COVID. These results are consistent with current understanding, but plasma is still being used inappropriately. Perhaps this large RCT will finally lead to de-adoption.
This trial lays to rest the debate around convalescent plasma for COVID-19. It is probably only of relevance to clinicians in centres where this treatment was used, in which case it should convince clinicians to stop the practice. However, for most clinicians (who do not have access to high-titre convalescent plasma), this study will not change practice.
Yet another trial showing no benefit of a once-touted treatment for COVID-19. This large randomized British trial of convalescent plasma found no benefit in preventing death or progression of disease.
Very well done study in a controversial area of COVID-19 therapy. The strengths include the size of the study and the well done discussion.
This very large trial nicely demonstrates that 2 infusions of convalescent plasma containing high titers of anti-spike antibodies did not change all-cause mortality or other outcomes in hospitalized patients with COVID 19 infection. One wonders if more infusions over more time might have shown a difference in some of the outcomes.