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Early Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized With Nonsevere COVID-19: An
Kelly Cho1,2, Sarah C Keithly3, Katherine E Kurgansky1
1Massachusetts Veterans Epidemiology Research and Information Center, Department of Veterans Affairs Office of Research and Development, Boston, Massachusetts, USA.
Insights
Early convalescent plasma transfusion did not significantly reduce 30-day mortality in nonsevere COVID-19 patients. This study found no meaningful difference in survival rates between treated and untreated groups.
Area of Science:
- Infectious Diseases
- Clinical Trials
- Public Health
Background:
- Convalescent plasma transfusion is an investigational therapy for COVID-19.
- Early intervention may impact patient outcomes in nonsevere COVID-19 cases.
Purpose of the Study:
- To emulate a target trial using observational data to assess the efficacy of early convalescent plasma transfusion in nonsevere COVID-19 patients.
- To compare 30-day mortality rates between patients receiving convalescent plasma and those who did not.
Main Methods:
- Utilized observational data from US veterans admitted to VA facilities between May and November 2020.
- Emulated a target trial design comparing convalescent plasma initiated within 2 days of eligibility.
- Employed inverse probability weighting to adjust for confounding factors and estimated mortality using cumulative incidence curves, risk differences, and hazard ratios.
Main Results:
- Analyzed 11,269 eligible person-trials from 4,755 patients; 402 received convalescent plasma.
- Observed 40 deaths in the plasma group and 671 in the nonplasma group.
- Estimated 30-day mortality risk was 6.5% (plasma) vs. 6.2% (nonplasma), with a risk difference of 0.30% and a hazard ratio of 1.04, indicating no significant difference.
Conclusions:
- Target trial emulation suggests no meaningful difference in 30-day mortality for nonsevere COVID-19 patients treated with convalescent plasma compared to untreated patients.
- Findings do not support the routine use of early convalescent plasma for nonsevere COVID-19 based on 30-day mortality.
- Clinical Trials Registration: NCT04545047.
Background:
Early convalescent plasma transfusion may reduce mortality in patients with nonsevere coronavirus disease 2019 (COVID-19).
Methods:
This study emulates a (hypothetical) target trial using observational data from a cohort of US veterans admitted to a Department of Veterans Affairs (VA) facility between 1 May and 17 November 2020 with nonsevere COVID-19. The intervention was convalescent plasma initiated within 2 days of eligibility. Thirty-day mortality was compared using cumulative incidence curves, risk differences, and hazard ratios estimated from pooled logistic models with inverse probability weighting to adjust for confounding.
Results:
Of 11 269 eligible person-trials contributed by 4755 patients, 402 trials were assigned to the convalescent plasma group. Forty and 671 deaths occurred within the plasma and nonplasma groups, respectively. The estimated 30-day mortality risk was 6.5% (95% confidence interval [CI], 4.0%-9.7%) in the plasma group and 6.2% (95% CI, 5.6%-7.0%) in the nonplasma group. The associated risk difference was 0.30% (95% CI, -2.30% to 3.60%) and the hazard ratio was 1.04 (95% CI, .64-1.62).
Conclusions:
Our target trial emulation estimated no meaningful differences in 30-day mortality between nonsevere COVID-19 patients treated and untreated with convalescent plasma. Clinical Trials Registration. NCT04545047.
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