“New York City was among the earliest and hardest hit by the COVID-19 pandemic in the United States, so during the study’s 16-day enrollment period in late March, our Health System had a large, diverse pool of COVID-19 patients from which to draw control patients, allowing us to use an aggressive matching algorithm,” says Nicole Bouvier, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai and co-senior author of the paper. “We are encouraged that our initial assessment offers evidence in support of convalescent plasma as an effective intervention, while remaining mindful that additional studies are needed to confirm these findings and draw more definitive conclusions in different populations.”
For this study, plasma recipients and control patients were 100 percent matched on their supplemental oxygen requirement on day zero, in addition to other baseline demographic factors and comorbidities. Of them, 69.2 percent were receiving high-flow oxygen and 10.3 percent were receiving invasive mechanical ventilation. By day 14, clinical condition had worsened in 18 percent of the plasma patients and 24.3 percent of the control patients. On days one and seven, the plasma group also showed a reduction in the proportion of patients with worsened oxygenation status, but that difference was not statistically significant. As of May 1, 12.8 percent of plasma recipients and 24.4 percent of the 1:4 matched control patients had died, with 71.8 percent and 66.7 percent, respectively, being discharged alive.
Patients were identified as eligible for COVID-19 convalescent plasma transfusion under the criteria established by the U.S. Food and Drug Administration (FDA) single patient emergency investigational new drug process. Plasma recipients were transfused with convalescent plasma from donors with a SARS-CoV-2 anti-spike antibody titer (level) of greater than or equal to 1:320 dilution and all were transfused with two units of convalescent plasma matching the recipient’s blood type.
Importantly, the cohort of matched control patients were retrospectively identified within the hospital’s electronic record database, using an aggressive matching algorithm designed by Mount Sinai biostatisticians that matched the plasma recipients to controls for three levels of patient information: 1) baseline demographics and comorbidities, including age; gender; smoking status; presence of obesity, diabetes, COPD or sleep apnea; and d-dimer and c-reactive protein at admission; 2) day of transfusion data, including supplemental oxygen requirement, length of hospital stay, minimal oxygen saturation, heart rate, respiratory rate, and systolic and diastolic BP; and 3) time series data up to the day of transfusion, including the use of hydroxychloroquine or azithromycin, intubation status, and, if intubated, duration of intubation. For controls patients, the day of transfusion was defined by the length of stay on which their respective recipient received their transfusion. To confirm the independent effect of convalescent plasma transfusion or improvement in oxygenation and survival, the team conducted a propensity score-matched analysis using The Mount Sinai Hospital’s COVID-19 confirmed patient pool from the same calendar period (March 24 to April 8, 2020). Among the predictors, exact matching was enforced on the administration of hydroxychloroquine and azithromycin, intubation status and duration, length of hospital stay, and oxygen requirement on the day of transfusion.
The COVID-19 pandemic poses an unprecedented challenge, as physicians and scientists struggle in real time to identify effective interventions against SARS-CoV-2 and its complications. The conclusions drawn from these data are not as robust as a prospective, randomized, placebo-controlled study, however this study has the unique strength of propensity score matching, which other case series have lacked.
“The efficacy of passive antibody transfer relies heavily on the quality of the donor convalescent plasma,” says Judith Aberg, MD, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and co-senior author of the paper. “Mount Sinai rapidly developed and clinically deployed an enzyme-linked immunosorbent antibody test (ELISA) to titrate SARS-CoV-2-specific antibodies in serum, enabling our center the unique ability to refer for blood collection only those convalescent donors with the highest plasma antibody levels. We are profoundly grateful for the generosity of thousands of anonymous residents of the tri-state area who recovered from COVID-19 and then volunteered to donate convalescent plasma for the benefit of others.”
“We’ve all experienced losses recently, whether it is our health or our freedom. As we face one of the largest pandemics of mankind, physicians and scientists will continue to unite in our common interests to return to a safe, normal life. It’s not easy, but this is a step forward.”– Sean Liu, MD PhD, Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai and first author of the paper.
To support COVID-19 research and response efforts, visit https://www.mountsinai.org/covid19research.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report‘s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty by U.S. News & World Report.
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