Roughly 30 severely ill Houston Methodist COVID-19 patients treated with the blood plasma of individuals who’d already fought off the disease have recovered and been discharged, one of the early signs emerging that the century-old approach might work against the deadly pandemic.
The patients include the first one, whose transfusion March 28 made national headlines as Methodist and Mount Sinai Medical Center in New York City became the first U.S. hospitals to enlist what’s known as convalescent serum therapy against the illness caused by the coronavirus circulating in Texas and around the world. Methodist had not previously provided an update on the patient.
“It’s too early to draw conclusions — this is a small sample size — but we’re very cautiously optimistic,” said Dr. James Musser, chairman of pathology and genomic medicine at Methodist. “We’ve certainly seen it’s safe in these patients, an important conclusion.”
The experimental therapy, which dates to the 1918 Spanish Influenza and was last used in the Ebola outbreak, is becoming a go-to response to the virus, which has infected more than 1 million Americans and killed in excess of 62,000. It has now been given to thousands of COVID-19 patients in the United States — 3,400 in a national trial, led by the Mayo Clinic, that includes more than 2,000 hospitals — as researchers search for weapons against the novel infection.
The therapy is based on the idea, well documented in laboratory research, that transfusing plasma from patients who’ve recovered from a virus transfers its healing power. Such plasma contains antibodies made by the immune system to attack the infection.
The Methodist data comes just after the New York Times reported that an administration official said the Food and Drug Administration likely will announce emergency drug approval for remdesivir, an anti-viral under study in Houston and some other cities. After preliminary study results Wednesday showed patients given the drug recovered 31 percent faster than those given a placebo, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said that remdesivir will become the standard of care for the illness.
Such rigorous study is lacking for convalescent serum therapy, despite its increasing popularity. The trials at Methodist and the Mayo Clinic, for instance, don’t include a comparison group that received a placebo, important to show whether those that received the drug might have improved without the intervention.
Johns Hopkins will conduct a randomized, placebo-controlled trial — smaller in scope than the Mayo Clinic trial — but it has not yet begun admitting patients.
The most encouraging study was probably one out of China last month that called convalescent serum therapy “a promising rescue option” for severe COVID-19. The study of 10 patients, published in the journal Proceedings of the National Academies of Sciences, found a single dose of plasma caused the coronavirus to disappear in patients’ blood in seven days; clinical symptoms to improve significantly within three days; and lung lesions to improve within seven days.
The rest of the positive signs using the therapy for COVID-19 involve mostly case reports.
Methodist, which plans to launch such a trial in the near future, hopes to submit an academic paper about its experience using convalescent serum therapy with COVID-19 patients next week, said Musser. It has treated about 50 critically ill patients with the therapy, and the vast majority of the 20 not discharged are still hospitalized.
The most critically ill COVID-19 patients, those on ventilators, die at a high rate with just supportive care — 39 percent, according to one recent study. The exact extent of the transfused Methodist patients’ severe illness was not clear.
One patient who received the plasma therapy, at Baylor St. Luke’s Medical Center, said she felt like “a new person” within a couple of days of receiving the transfusion.
“It was like a breath of fresh air,” said Debra Ammons, 64, an HISD bus driver back at home after 11 days in the hospital. “After getting the therapy, I just felt different.”
Ammons was taken to the ER, unresponsive, after complaining she couldn’t breathe two days after Easter. She was diagnosed with COVID-19 double pneumonia and put on oxygen before she was transfused.
Ammons was one of 16 severely ill St. Luke’s COVID-19 patients who’ve received the therapy. Most remain in the hospital.
Mount Sinai, which has not reported data from its study, has transfused plasma from recovered patients’ blood into roughly 200 COVID-19 patients, many of whom have been discharged, said a spokeswoman. That includes its first recipient, whose transfusion the same evening as the Methodist transfusion only became public a week later. The two patients were the nation’s first to get the therapy.
The Mount Sinai spokeswoman noted that roughly 45,000 people in the area have “reached out to see if they qualify for antibody testing” needed to show their antibody activity is robust enough to be candidates for donating.
The Gulf Coast Regional Blood Center is still looking for more donors as it partners with Baylor College of Medicine to bring plasma transfusions to more patients in the Houston area. A spokeswoman said that the center has collected plasma from more than three dozen donors — 12 donations have gone to patients so far — and has worked with 12 facilities.
Dr. Michael Joyner, a Mayo Clinic anesthesiologist and the national trial’s principal investigator, said he has a meeting scheduled with FDA officials next week — he’ll bring preliminary data — where he’ll get guidance on “how to frame things going forward.” He is working on a registry of therapy recipients in an effort to find comparison groups.
He said he’s getting lots of emails and other communication from institutions reporting positive stories.
“We’re hopeful,” said Joyner, who reports the number of trial participants has significantly picked up in the last week to 10 days. “I have to be objective, wait for careful analysis of the numbers, but case reports and institutional enthusiasm for the program are encouraging.”