EFFECT OF CONVALESCENT PLASMA ON MORTALITY IN PATIENTS WITH COVID-19 PNEUMONIA

Abstract

Background

Convalescent plasma, widely utilized in viral infections that induce neutralizing antibodies, has been proposed for COVID-19, and preliminary evidence shows that it might have beneficial effect. Our objective was to compare epidemiological characteristics and outcomes between patients who received convalescent plasma for COVID-19 and those who did not, admitted to hospitals in Buenos Aires Province, Argentina, throughout the pandemic.

Methods

This is a multicenter, retrospective cohort study of 2-month duration beginning on June 1, 2020, including unselected, consecutive adult patients with diagnosed COVID-19, admitted to 215 hospitals with pneumonia. Epidemiological and clinical variables were registered in the Provincial Hospital Bed Management System. Convalescent plasma was supplied as part of a centralized, expanded access program.

Results

We analyzed 3,529 patients with pneumonia, predominantly male, aged 62±17, with arterial hypertension and diabetes as main comorbidities; 51.4% were admitted to the ward, 27.1% to the Intensive Care Unit (ICU), and 21.7% to the ICU with mechanical ventilation requirement (ICU-MV). 28-day mortality was 34.9%; and was 26.3%, 30.1% and 61.4% for ward, ICU and ICU-MV patients. Convalescent plasma was administered to 868 patients (24.6%); their 28-day mortality was significantly lower (25.5% vs. 38.0%, p<0.001). No major adverse effects occurred.

Logistic regression analysis identified age, ICU admission with and without MV requirement, diabetes and preexistent cardiovascular disease as independent predictors of 28-day mortality, whereas convalescent plasma administration acted as a protective factor.

Conclusions

Our study suggests that the administration of convalescent plasma in COVID-19 pneumonia admitted to the hospital might be associated with decreased mortality.

Key Points

Preliminary evidence showed that convalescent plasma might be beneficial in COVID-19.
In a cohort of 3,529 patients with pneumonia due to COVID-19, convalescent plasma was administered to 868 patients, without major adverse effects.
Convalescent plasma was independently associated with decreased mortality.

SciScore for 10.1101/2020.10.08.20202606: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Institutional Review Board Statement	IRB: This study was approved by the Central Ethics Committee of the Ministry of Health of Buenos Aires Province (Expedient 2020-14965594). IACUC: In the protocol of the present study, the Central Ethics Committee acts as an Institutional Evaluation Committee in use of the powers provided for by Decree 3385/08 as a research project, in which the Ministry of Health of the Province of Buenos Aires acts both as sponsor and center. Consent: The administration of convalescent plasma required signed consent from each patient or legal representative, according to CROCPD-BA regulations (Expedient 2919/2123/2020).
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.
Sex as a biological variable	not detected.

Table 2: Resources

No key resources detected.

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

Nevertheless, older age was an independent predictor of mortality, as expected [23,34] Limitations: The main limitation of this study is the lack of randomized assignment of convalescent plasma administration. Additionally, unmeasured confounders might have influenced the results, such as other risk factors or treatments. Since severity of illness on admission could not be evaluated with an established score, misclassification of patients might have occurred. However, the use of severity of illness on admission as a surrogate of acuity has already been utilized [3]. A more detailed analysis of the clinical variables collected could not be done, because of the type of data recorded in the register. Finally, the reason why assistant physicians chose not to administer convalescent plasma to patients with COVID-19 pneumonia fulfilling the inclusion criteria are unknown, but we speculate that some physicians might have felt uncomfortable with prescribing an experimental treatment to their patients. In conclusion, our study suggests that the administration of convalescent plasma in COVID-19 pneumonia might be associated with decreased mortality. Large, well-designed clinical trials are required to confirm these findings.

Results from TrialIdentifier: No clinical trial numbers were referenced.

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

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