BRONX, N.Y.—Montefiore Health System, the Albert Einstein College of Medicine and NYU Langone have launched a new clinical trial to study if convalescent plasma, which is taken from people who have recovered from COVID-19, is effective in treating the disease.
The body’s immune response to viral infections includes creating antibodies, which could possibly prevent reinfection with COVID-19 and successfully help people who are sick with COVID-19 fight the virus. This therapy, known as convalescent plasma therapy, has been deployed in viral outbreaks over the past century. It has shown promise in reducing the severity of illness and improving survival rates.
“We created this study based on evidence from the pre-antibiotic era, but there has been no scientific proof it is really effective,” said study co-leader Liise-anne Pirofski, M.D., chief of infectious diseases at Montefiore and Einstein, and a leader of the national COVID-19 Convalescent Plasma Project.
The randomized, controlled trial will enroll 300 people with COVID-19 respiratory symptoms. Half will receive plasma that contains antibodies to the SARS-CoV-2 coronavirus, and the remaining half will receive placebo. The trial is looking for candidates who have experienced respiratory symptoms for less than one week, have required some supplemental oxygen, or have been in the hospital for less than four days.
Previous studies suggest that convalescent plasma may be helpful treatment for other coronaviruses, including SARS. This trial aims to provide proof that it is effective for COVID-19 patients. Last month, Pirofski co-authored a widely cited viewpoint in the Journal of Clinical Investigation. The article champions the use of convalescent serum as a COVID-19 treatment.
“In the twenty-first century, there have been two other epidemics with coronaviruses that were associated with high mortality, SARS1 in 2003 and Middle East respiratory syndrome (MERS) in 2012,” state the authors of the viewpoint. “The SARS1 epidemic was contained, but MERS became endemic in the Middle East and triggered a secondary major outbreak in South Korea. In both outbreaks, the high mortality and absence of effective therapies led to the use of convalescent serum.”
“The largest study involved the treatment of 80 patients with SARS in Hong Kong. Patients treated before day 14 had improved prognosis defined by discharge from hospital before day 22, consistent with the notion that earlier administration is more likely to be effective,” they write. “In addition, those who were PCR positive and seronegative for coronavirus at the time of therapy had improved prognosis.”
Since the pandemic first reached the U.S., Montefiore has successfully treated and discharged approximately 4,000 severely ill COVID-19 patients from its hospitals. This presents an opportunity to get plasma from former patients, and to use these antibodies to treat a community which has been disproportionally affected by COVID-19.
“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,” noted Mila Ortigoza, M.D., Ph.D., an instructor in the departments of Medicine and Microbiology at NYU Langone Health and co-lead study investigator. “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.”
The first Montefiore plasma donors have come from a synagogue, Young Israel of New Rochelle, in New York. The community, which has been impacted by one of the largest clusters of COVID-19 cases in the U.S., is now providing a beacon of hope.
“To have so many people who have recovered from COVID-19 donate their plasma and make this research possible, and potentially help people they have never met, is an incredible celebration of the human spirit. We are overwhelmed by the generosity of recovered patients and are confident this trial will help us learn if convalescent plasma is effective against COVID-19,” concluded Pirofski.