Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Worldwide, the COVID-19 pandemic has caused a decline in blood donations, between 30% and 70% in some of the most affected countries. In Spain, during the initial eight weeks after the State of Emergency was decreed on 14 March 2020, in the weekly reports of the Health Ministry, an average decrease of 20% was observed between 11 and week 25 compared with the 2018 donation. We aimed to investigate the impact of the COVID-19 pandemic on blood donations and blood distribution in four autonomous communities, and to explore the evolution of the consumption of blood components (BCs) in ten hospitals of six autonomous communities. We performed a prospective study of grouped cohorts on the donation and distribution of blood in four regional transfusion centers in four autonomous communities in Spain, and a retrospective study of the consumption of blood components in ten hospitals in six autonomous communities. Regarding donations, there was no significant decrease in donations, with differences between autonomous communities, which started between 1 and 15 March 2020 (−11%). The increase in donations in phase II (from 26 May 2020) stands out. Regarding consumption, there was a significant reduction in the consumption of packed red blood cells (RBCs) (24.5%), plasma (45.3%), and platelets (25.3%) in the central period (16 March–10 May). The reduction in the consumption of RBCs was significant in the period from 1–15 March. Conclusions: The COVID-19 pandemic has affected the donation and consumption of BCs.

Background and Objectives: There is a concern about a possible deleterious effect of pathogen reduction (PR) with methylene blue (MB) on the function of immunoglobulins of COVID-19 convalescent plasma (CCP). We have evaluated whether MB-treated CCP is associated with a poorer clinical response compared to other inactivation systems at the ConPlas-19 clinical trial. Materials andMethods: This was an ad hoc sub-study of the ConPlas-19 clinical trial comparing the proportion of patients transfused with MB-treated CCP who had a worsening of respiration versus those treated with amotosalen (AM) or riboflavin (RB).Results: One-hundred and seventy-five inpatients with SARS-CoV-2 pneumonia were transfused with a single CCP unit. The inactivation system of the CCP units transfused was MB in 90 patients (51.4%), RB in 60 (34.3%) and AM in 25 (14.3%). Five out of 90 patients (5.6%) transfused with MB-treated CCP had worsening respiration compared to 9 out of 85 patients (10.6%) treated with alternative PR methods (p = 0.220). Of note, MB showed a trend towards a lower rate of respiratory progressions at 28 days (risk ratio, 0.52; 95% confidence interval, 0.18-1.50). Conclusion:Our data suggest that MB-treated CCP does not provide a worse clinical outcome compared to the other PR methods for the treatment of COVID-19.

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