A clinical trial now underway is looking at whether blood plasma donated by people recovered from 2019 coronavirus disease (COVID-19) could be used to treat other people with the pandemic virus.
Led by researchers from NYU Grossman School of Medicine, Montefiore Health System, and Albert Einstein College of Medicine, the trial will seek to determine whether “convalescent plasma,” if injected into patients’ blood, can keep them from developing the most severe forms of respiratory distress.
Plasma treatments contain antibodies, blood proteins which are part of the immune system. Shaped such that they can attach to viruses, antibodies glom onto and tag them for removal from the body, researchers say. Immune cells make antibodies that are specific to each infection, such that the body is more ready the next time it encounters a virus. Vaccines work by triggering such reactions, but “passive” treatments like plasma inject antibodies pre-trained to attack the virus in question.
“Infections like the new coronavirus that jump into humans from animals are dangerous because we have no antibodies against them, so we hope to learn if supplying them can save lives,” says co-lead study investigator, Mila Ortigoza, MD, PhD, an instructor in the Departments of Medicine and Microbiology at NYU Langone Health. “Vaccines may not be available for more than a year. In the meantime, and given the lack of natural immunity and available vaccines, plasma therapy may help to provide the body what it needs to fight the infection.”
Beyond emergency care, there are no proven treatment options for COVID-19, the infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Convalescent plasma becomes a more viable treatment option as the numbers of recovered people continue to grow, says Dr. Ortigoza. While researchers do not know exactly how much antibody is needed, the theory is that plasma taken from one patient may be enough to treat one to three patients.
The current, randomized phase II trial seeks to enroll 300 hospitalized patients aged 18 years or more across 7 hospital centers. The trial is designed to focus on patients within a tight time window (three to seven days after symptom onset), during which they are sick enough to be hospitalized, but before the onset of overwhelming respiratory distress driven by systemic inflammation.
The goal of the trial is to see whether plasma from people who have recovered from COVID-19 can improve oxygenation and reduce the requirement for mechanical ventilation, intensive care unit (ICU) admission, and death. Eligible subjects will be randomized in a 1:1 ratio to receive either anti–SARS-CoV-2 plasma or placebo (saline solution), with the former donated by people at the New York Blood Center (NYBC).
Within the NYU Langone arm of the trial, much of plasma was donated by employees, including frontline healthcare workers, who have recovered from the infection. After NYU Langone administration issued a call for plasma on April 4, roughly 300 employees volunteered to donate within days. Many have gone to NYBC to donate.
“At this point, almost everyone in New York has a friend or loved one who has been diagnosed with COVID-19,” says Montefiore Health System and Albert Einstein College of Medicine principal investigator Liise-anne Pirofski, MD, chief of infectious diseases at Montefiore and Einstein and a leader of the national COVID-19 Convalescent Plasma Project. “The clinical trial provides an opportunity for people who have recovered from this devastating disease to help others in need. We are humbled by the outpouring of donors who have come forth to provide their plasma and honored to have the opportunity to determine scientifically if convalescent plasma is a treatment option for COVID-19 amid this unprecedented pandemic.”
Also study investigators from NYU Langone are David Kaminetzky, MD; Gillian G. Baptiste, MD; Tania Kupferman, MD; Rabi Upadhyay; Stephanie Sterling, MD; Lalitha Parameswaran, MD; Shadi Yaghi, MD; Aaron S. Lord, MD; Mary K. O’Keeffe, MD; and Anthony Corcoran, MD. These efforts have been led and supported by Corita R. Grudzen, MD, vice chair for research in the Ronald O. Perelman Department of Emergency Medicine, and Judith S. Hochman, MD, the Harold Snyder Family Professor of Cardiology and senior associate dean for clinical sciences at NYU Langone.