A multicenter team of investigators reported on the administration of coronavirus disease 2019 (COVID-19) convalescent plasma to patients with severe COVID-19 in the Yale-New Haven Health System and identified predictors of mortality. Their findings were presented by Sabrina L. Browning, MD, of the Yale University School of Medicine and Yale Cancer Center, New Haven, Connecticut, at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
“Despite advancements in our knowledge of this disease, standard management for SARS-CoV-2 infection continues to largely be supportive care,” says Dr Browning. “The information regarding [the use of convalescent plasma transfusion] effectiveness remains limited.”
The investigators evaluated outcomes in hospitalized adult patients with severe or life-threatening COVID-19 treated with convalescent plasma therapy at 5 hospitals in the Yale-New Haven Health System between April 12 and June 14, 2020.
Eligible patients who enrolled in this US COVID-19 Expanded Access Program, which was sponsored by the Food and Drug Administration and led by the Mayo Clinic, were required to have severe or life-threatening disease, and contraindications included a duration of less than 10 days after the first positive COVID-19 test or the clinical suspicion or confirmation of thrombosis. Due to the increased thrombotic risk associated with COVID-19, which could be exacerbated with the administration of donor blood products, all patients receiving convalescent plasma received anticoagulation at the time of transfusion and for at least 72 hours afterward.
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Participants were transfused 1 unit of COVID-19 convalescent plasma, and patient outcomes were assessed at 7, 14, and 28 days after transfusion. The investigators also evaluated predictors of mortality in the cohort.
Of 105 patients (median age, 62 years; range, 28-88 years), 62.9% were men, and 56.2% identified as non-White, while 33.3% identified as Hispanic or Latinx. Notable patient characteristics and comorbidities included body mass index greater than 30 (47.6%), extreme obesity (13.3%), diabetes mellitus (42.9%), hypertension (61.9%), and hyperlipidemia (53.3%). Some patients were also receiving concomitant therapy for COVID-19, including hydroxychloroquine (79.0%), tocilizumab (79.0%), and remdesivir (23.8%).
Within 7 days of convalescent plasma transfusion, 42.9% of patients improved (median 4 days to improvement) according to the World Health Organization (WHO) ordinal scale score, which measures illness severity over time, and 9.5% experienced worsening oxygenation, indicated by an increasing WHO score.
At Day 28 post-transfusion, 52.4% of patients were alive and discharged from the hospital. Of the 87 patients in the ICU at the time of transfusion, 64.4% were transitioned to non-ICU care at a median of 8 days after transfusion, and 63.2% were ultimately discharged. Overall, the patient mortality rate was 10.4% at Day 7, 20.9% at Day 14, and 28.5% at Day 28 post-transfusion.
D dimer levels (>5 mg/L FEU) at 24 hours (OR, 2.29; 95% CI, 1.18-6.72; P =.0332), 48 hours (OR, 3.64; 95% CI, 1.44-9.70; P =.0125), and 72 hours (OR, 2.99; 95% CI, 1.23-7.66; P =.0313) after transfusion were predictors of mortality. Elevated ferritin level (>3000 ng/mL) on the day of transfusion was associated with increased mortality (OR, 5.14; 95% CI, 1.34-19.68).
“These data in our patient cohort are encouraging. Overall, we highlight the importance of conducting larger case control and randomized placebo controlled trials to further elucidate the efficacy and safety of COVID-19 convalescent plasma therapy; these investigations are underway by our group,” says Dr Browning.
Disclosures: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Read more of Hematology Advisor’s coverage of the ASH 2020 meeting by visiting the conference page.
Reference
Browning SL, Gormally M, Briggs N, et al. Use of convalescent plasma therapy in severe coronavirus disease 2019: the Yale-New Haven health system. Presented at: 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 101.
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