Lachelle Sosa Jones of New Haven, Covid-19 survivor and prospective plasma donor
When medical residents Neima Briggs and Michael Gormally aren’t in the Yale New Haven Hospital ICU caring for patients with Covid-19, they’re conferring with a group of doctors in a nationwide study on the use of convalescent plasma therapy to combat the disease caused by the novel coronavirus.
Convalescent plasma is the term used for plasma that’s removed from the blood of a person who has recovered, or convalesced, from a disease, and then transfused into a patient still battling it.
The recovered patient’s plasma, the fluid component of blood, contains antibodies, which the body generates to fight off a virus or bacteria. “Giving plasma from a donor that got better from Covid-19 to a patient who is just starting to get sick might make them recover more quickly,” Gormally said.
With no proven or fully approved treatments for Covid-19, the hope, Briggs said, is that “by collecting that plasma and transfusing it into a sick recipient, the antibodies will help neutralize the virus in the recipient as well.”
It’s a hope that has Briggs and Gormally acting as liaisons among a patient with Covid-19, the patient’s primary healthcare team, the Yale blood bank, and a multidisciplinary team across the Yale New Haven Health System that includes leaders in hematology, critical care medicine, and pharmacy.
The model of collaboration is invaluable, according to Dr. Sabrina Browning, a hematology-oncology fellow who’s directly involved in the enrollment process and in ongoing discussions regarding the safety of convalescent plasma.
“Being in a group with so many specialties helps us tackle issues that arise with this therapy from every angle,” she said.
That team is led by Mahalia Desruisseaux, Yale New Haven Health’s principal investigator in a federally funded Expanded Access Program (EAP) that has thousands of hospitals, doctors, and scientists across the nation collaborating to realize the full potential of convalescent plasma therapy.
In early April, the Food & Drug Administration designated the Mayo Clinic as the lead institution for the EAP, which allows for easy access to convalescent plasma in order to reach the greatest number of patients. YNHH registered to participate in the program shortly after.
“Our role is to make this treatment available to the hospitalized Covid patients who need it, and to evaluate the efficacy and safety of plasma therapy in those patients,” she said.
Desruisseaux said the underlying basis for exploring convalescent plasma as a treatment for Covid-19 was that “the therapy has been used for centuries,” from treating diphtheria in the late 1800s, to the 1918 Spanish flu, as well as, more recently, SARS, Ebola, and H1N1.
It’s used, in addition, to treat burn, trauma, and cancer patients, leading the New York Blood Center to dub it “liquid gold.”
Principal investigator Mahalia Desruisseaux.
Desruisseaux (pictured) pointed to a March report in the Journal of the American Medical Association of a small study showing the dramatic improvement in five critically ill Covid-19 patients on ventilators in Shenzen, China after receiving convalescent plasma treatments. Three were eventually discharged while the others’ conditions stabilized.
Those promising results aside, she cautioned that “we don’t know its true side effect potential.”
When used to treat non-Covid diseases in the past, convalescent plasma has occasionally bolstered the virus’ strength instead of cutting it down, she said. It can also exacerbate fluid overload in someone with heart failure..
In addition to the risks inherent in all blood transfusions, there are other concerns, according to Dr. Christopher Tormey, the director of Yale New Haven Hospital’s Transfusion Medicine Service.
“We worry about people with Covid having pulmonary or lung reactions to infusion that can be pretty severe, as well as severe allergic reactions to blood products that can range from a few hives to full-blown anaphylactic shock,” he said.
There’s another limitation. The therapy has received temporary authorization for emergency investigational use by the FDA in an effort to most quickly treat the greatest number of patients. While the protocol requires participating physicians to monitor and report adverse events and unanticipated problems, those kind of “observational studies,” as Tormey called them, aren’t enough to show whether convalescent plasma will help those patients.
Without a comparison group afforded by a clinical trial, “there’s no way to say whether or not these individuals would have improved to begin with,” Desruisseaux said, “or whether they got better due to another of the multiple concomitant therapies they were getting.”
Another limiting factor is the scarcity of donors, she said.
The FDA requires that recovered patients be symptom-free for 14 days and test negative for Covid-19, or be symptom-free for 28 days without a negative test.
“These time delays have been built in for safety purposes,” Desruisseaux said, but it means “New York City is the most fertile region for donors,” with Connecticut, and in particular the New Haven area, lagging behind.
On the bright side, once more people in this area have recovered, “it’s likely that dozens and dozens of units will become available,” Tormey said.
“You think of a seesaw, we’re already approaching the better portion of the seesaw where we now have more recovering individuals than we do individuals who are severely ill.”
Many of those recovering individuals, Tormey said, “have reached out to us to say how can I help, where can I donate.”
For those interested in becoming a donor in the Connecticut region, he recommended visiting the websites of the New York Blood Center, Rhode Island Blood Center, or the American Red Cross in Farmington and completing the online form as part of an initial screen.
One of those prospective donors is Lachelle Sosa, 42, of New Haven. Having tested positive for Covid-19 in early April, she’s fully recovered.
“I’d like to donate in honor of a family member who was about to go on a ventilator and was asked if she’d like to try an experimental treatment to help her get better,” she said. “And she did. I’m also very grateful that I got better and want to pay it forward.”
Bhushan Shah, assistant chief technologist at the Yale-New Haven Blood Bank, with unit of convalescent plasma. The unit was about to be thawed for issue to a patient with Covid-19 and would be infused that afternoon.
Donating plasma, Tormey said, “is similar to donating blood, except the blood drawn from your arm is sent through a machine that collects plasma before returning your red cells and platelets.”
A single donation can treat up to three patients.
The availability of more plasma means quicker delivery to the patient. “When we initially started doing this, it took two or three days to get a plasma infusion, and we’ve now gotten that down to under 24 hours,” Tormey said.
That early intervention could be significant, according to Briggs, the medical resident.
“We think that patients whose bodies have not generated a strong adaptive immune response may lack the protective antibodies necessary to fight the virus and those patients may be better suited to receive convalescent plasma,” he said. “In theory you can neutralize the virus before it gets to that severe stage.”
If that’s seemingly cause for cautious optimism, the spirit of teamwork among the doctors overall has made the initiative, as Desruisseaux put it, “extremely rewarding.”
Gormally agreed. “All of the core members of our team are physician-scientists, and what we’re dealing with now really represents the quintessential motivation that got us all into this career,” he said.
“As a part of this project, what is so exciting is the potential to apply our work to have immediate and life-saving impact, and that’s to take really fundamental things that we can study in a lab and actually apply them to patients to make them better.”
For more information on blood donation requirements, visit this site.
Interesting information, I hope they can figure out who is a safer choice of recipient for plasma treatment and figure out who will be more likely to have an adverse reaction. I would guess those who don't seem to have a strong immune response to the virus would be a better choice, whereas people who have an overactive immune response would not be.