2 COVID-19 patients receive serum therapy
Houston Methodist Hospital transfused blood from recovered COVID-19 patients into two additional severely ill patients Friday, the same day the federal government made it easier for people afflicted with the coronavirus to receive the experimental therapy.
Doctors offered the therapy to the new patients just before the Food and Drug Administration approved a clinical trial that allows research hospitals to transfuse patients without applying for permission each time, Methodist said in a news release.
Four total patients at Methodist now have received what’s known as convalescent serum therapy, a concept that dates back to the 1918 Spanish flu pandemic. Methodist appeared to become the nation’s first hospital to try the approach in COVID-19 patients when it transfused the plasma blood of a recovered patient into two patients in critical condition
March 28.
The hospital Friday said that the patients are still alive, but provided no more detail on their condition.
In response to a question on the hospital’s Facebook page, a prominent Methodist doctor not involved in the project said “the trial is working exceptionally well.”
“The initial results have been very promising and the improvement has been dramatic in some cases,” wrote Dr. Jason Knight, chief medical officer at The Woodlands hospital.
In Friday’s news release, Methodist doctors cautioned that “it could be some time before the therapy’s effectiveness in individual patients is known,” a seeming signal it won’t provide updates on the patients any time soon.
Plasma from someone who has recovered from COVID-19 contains antibodies made by the immune system to attack the virus. The hope is that transfusing
such plasma into a patient still fighting the virus may transfer the power of the antibodies into a healing, possibly life-saving therapy.
There is no treatment approved for the illness caused by the novel coronavirus. It has now been diagnosed in more than 300,000 people in the U.S., killing in excess of 8,000.
Ten fully recovered former Methodist patients have now donated their plasma, and more donations are scheduled for next week, according to the hospital.
The FDA in late March approved the therapy as an “emergency investigational new drug,” meaning a hospital could request that the agency allow its use each time there was a good candidate. Now that there’s no such regulation, hospitals can provide the therapy to any patients who meet the trial protocol without the FDA’s case-by-case involvement.
Such FDA fast-tracking is rare. The agency sometimes acts quickly to grant individuals’ access to experimental drugs on a compassionate basis, but it typically takes a public health crisis to do so on such a wide scale.
“This is an important area of research — the use of products made from a recovered patient’s blood to potentially treat COVID-19,” said FDA Commissioner Dr. Stephen Hahn, who previously served as a top administrator at MD Anderson Cancer Center. “The FDA played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma.”
Forty institutions are taking part in the clinical trial, which is being led by the Mayo Clinic and Johns Hopkins University. Methodist is working with Baylor College of Medicine for the trial’s Houston arm.
Mount Sinai Medical Center said last week it also transfused the blood of a recovered the evening of March 28. They and Methodist were the first two institution to enlist the therapy against COVID-19.
In addition to its use during the 1918 flu pandemic, convalescent serum therapy also was used for the measles, mumps and polio in the first half of the 20th century. It became less relevant with the advent of vaccines and antiviral drugs.
But this is not the first revival of convalescent serum therapy. It was used for SARS in 2003, swine flu in 2009 and Ebola in 2014.