By Maria Ann Roglieri
Dr. Anna Komorowski, Medical Director of the Medical Oncology and Hematology Program at Phelps Hospital/Northwell Health Cancer Institute in Sleepy Hollow, and her healthcare team, have initiated a convalescent plasma study at Phelps Memorial Hospital. The study is part of an FDA-sponsored trial organized by the Mayo Clinic and involves over 200 institutions across the country with 1,978 sites, and 4,524 patients enrolled nationwide (these numbers are expanding every day).
The immune systems of patients who are recovering (convalescing) from COVID-19 are likely to produce antibodies to the virus, which can in turn be harvested and injected into the blood of current sufferers, thereby bolstering their ability to fight the disease.
Dr. Komorowski’s team consists of two physicians, Dr. Heather Katz and Dr. Keyur Thakar, one research nurse, Barbara Turner, and one nurse practitioner, Joanna Sanzone — with the assistance of the entire hematology/oncology administrative staff at Phelps.
Pre-COVID-19, the team had been preparing for several clinical trials in oncology. The physicians and research nurse began their first clinical trial on March 10 for breast cancer. When it became apparent that COVID-19 was becoming a pandemic that would have a nationwide impact, the team put its other planned cancer trials on hold, applied (and was accepted) to participate in the national Mayo Clinic convalescent plasma trial.
Currently at Phelps/Northwell there are 63 patients in the hospital with COVID-19, and 15 of those are on ventilators. The convalescent plasma study was opened just last week and already over 40 of these COVID-19 patients are participating. Every day more and more patients are being enrolled — including patients transferred from other hospitals. The study has quickly become one of the leading studies in the area.
The use of antibody-enriched plasma arcs back from this pandemic to one a century ago: Komorowski’s team has just enrolled an 80-year-old patient whose father was treated with convalescent plasma (in that case harvested from a horse!) for the Spanish flu in 1918. The patient credits the transfusion with saving his father’s life; the team hopes he will soon be able to say the same about his own transfusion of human plasma a century later.
The convalescent plasma study at Phelps/Northwell is open to patients who have been diagnosed as positive for COVID-19, are over the age of 18, are symptomatic and are sick enough to be hospitalized. This applies to patients who are severely sick (experiencing shortness of breath or pneumonia) or who are experiencing life-threatening symptoms such as septic shock or multiple organ dysfunction.
Dr. Komorowski is excited about the study but also cautions that because convalescent plasma transfusions were not found to be useful for Ebola patients, they may not prove useful for COVID-19 patients. But as she points out, “We are doing convalescent plasma transfusions for COVID-19 patients because we don’t have any good treatment yet.”
Generally, transfusions are very safe; one in a million patients on average experience some side effects from the transfusions. Side effects may include an allergic reaction; an abrupt inflammation in the lungs known as TRAILY (transfusion-associated lung injury); or a fluid overload known as TACO (transfusion-associated circulatory overload). Historical data from convalescent plasma transfusion for other conditions (such as measles or Spanish flu) show that patients typically respond to the treatment in two to seven days.
Patients receiving the convalescent plasma are given an average dose of 200 mL (400 mL for patients with weight over 209 pounds) and are tracked for four to 12 hours after infusion to make sure they are tolerating it well. Any adverse reactions are reported directly to the Mayo Clinic. Patients are then checked on the seventh and again on the 30th day after transfusion. Eighty percent of the patients develop mild to moderate disease; 20% develop pneumonia, and out of that 20% about 5% can develop life-threatening disease. Cases of the lingering disease were observed in some patients for over a month.
The Phelps/Northwell team reports that preliminary results are encouraging, and they expect more detailed positive results in a few weeks. The first patient who received the plasma transfusion was in his 70’s and has already been discharged. As he was improving already before the treatment, it is unclear whether or not he benefited from the transfusion as well. Komorowski indicated that her team is also strongly interested in ultimately giving COVID-19 patients convalescent plasma transfusions a little sooner, even after the first week when it becomes clear that a patient’s immune system is not handling the virus well. It is hoped that an infusion of antibodies would help the patient overcome the virus.
The Phelps/Northwell team hopes to run the trial as long as possible and to open it up to as many people as possible going forward. This will depend on the availability of donor plasma, as well as the availability of money to cover the many costs involved, including costs of donor screening, blood processing, blood storage, transfusion delivery and administrative costs — and for the Mayo Clinic.
To succeed, the program needs donors. Anyone who has recovered from COVID-19 can get tested for antibodies to the virus and then donate blood. The nearest blood donation center is located at 525 Executive Boulevard in Elmsford. Visit https://nybloodcenter.org/ or call (800) 933-2566 to register for an appointment.
Those who have not been sick with COVID-19 can help by donating money to Phelps Memorial Hospital/Northwell and/or to meal donations to the medical staff. Monetary gifts can be made directly to Phelps COVID-19 Emergency Response Fund by visiting https://phelps.northwell.edu/get-involved/ways-to-give. The Phelps Meal Train allows community members to sign up to send a meal from a local restaurant to hospital staff members. (Those ordering a delivery from a local restaurant are also helping to support our local businesses.) There are three meal slots per day. For more information, see https://www.mealtrain.com/trains/nn762o
“When we had our first COVID-19 patient, we were all frightened,” says Komorowski. “Since then the number of COVID-19 patients has snowballed and it has been emotionally overwhelming for us. It is heartbreaking to watch what happens with some of these patients. At the same time, it has been our blessing that we, at a community hospital, can conduct this clinical trial that is really for larger hospitals. We are proud to be able to help our community of the rivertowns and our larger community of fellow Americans.”
Just this week, Phelps/Northwell applied to conduct another trial on the effect of the antiviral medication remdesivir on COVID-19 patients. Stay tuned!