UTHealth and Baylor College of Medicine have begun enrolling participants in rigorous studies investigating the therapeutic benefit of recovered COVID-19 patients’ blood plasma, evidence needed to facilitate greater use of the popular but still experimental century-old treatment.

“This is exactly the study we need to be doing to determine once and for all if this therapy works,” said Dr. Luis Ostrosky, study co-investigator and infectious disease specialist at McGovern Medical School at UTHealth. “Physicians have been using the therapy to try to save patients during the pandemic, knowing it’s safe but not knowing if it really works. Now, we’re going to find that out.”

The trials will compare outcomes in participants who receive plasma and those who receive a placebo, the so-called gold standard of testing. The Food and Drug Administration reportedly has put on hold a plan to allow easier access to the therapy because of the lack of such testing.

The treatment, known as convalescent serum therapy, is based on the idea that transfusing plasma from patients who’ve recovered from a virus transfers its healing powers, contained in antibodies made by the immune system to attack the infection. First used during the 1918 Spanish Influenza, it has become one of the go-to treatments for the disease caused by the coronavirus.

The therapy initially came in the spotlight for COVID-19 in late March, when medical teams at Houston Methodist and Mount Sinai Medical Center in New York City independently and on the same evening became the first U.S. hospitals to transfuse patients with recovered patients’ plasma. Those initial patients recovered and went home.

A leading Methodist official Wednesday said the hospital system isn’t happy the FDA has delayed its plan to grant emergency approval to the therapy. Such approval would allow all hospitals to deploy the therapy, not just academic ones as part of clinical trials.

On HoustonChronicle.com: Blood plasma therapy for COVID-19 patients coming to more Houston hospitals

“We’re disappointed the FDA has delayed its plan to expand access,” said Ed Jones, director of the Houston Methodist Research Institute. “We’re eager to deploy the therapy at our suburban hospitals, where they don’t have the tools in their arsenal that we do in the medical center.”

Jones argued that evidence from Methodist’s own studies show the therapy is safe and effective. The latest, published in the Journal of Pathology last week, found that 136 patients who received plasma were more likely to be alive four weeks later than 251 patients who did not receive it. The latter group did not receive a placebo; researchers instead used medical records of similar patients to make the comparison.

But such evidence wasn’t considered rigorous enough by leading government officials. The New York Times reported Wednesday that a group of top federal health officials, including Dr. Francis Collins and Dr. Anthony Fauci convinced the FDA to put a hold on its plan, arguing that existing data is not strong enough, that results are needed from a trial randomly assigning patients to a plasma arm and a placebo arm.

The FDA’s planned emergency authorization notes the history of plasma’s use in disease outbreaks, animal research and numerous COVID-19 plasma clinical trials. Those have established that the therapy works better when provided earlier in the disease process and when the plasma’s antibody levels are highest. The Mayo Clinic has published results from tens of thousands of patients enrolled through an expanded-use program that showed plasma is safe.

On Wednesday, Memorial Hermann enrolled the first hospital patient in Texas as part of a randomized trial. Because the trial is “double blinded,” neither the patient nor the staffer providing the shot will know whether it contains plasma or a placebo.

The nationally study was established and is being led by New York University and Montefiore Medical Center/Albert Einstein College of Medicine. UTHealth, Yale and the University of Miami were recently added to the study.

UTHealth will administer the study at three of its affiliated Memorial Hermann hospitals — the ones in the Texas Medical Center, southwest Houston and the Heights — as well as the Harris Health System’s Lyndon B. Johnson Hospital and the University of Texas Health Science Center at Tyler.

On HoustonChronicle.com: FDA fast tracking makes Houston Methodist one of first hospitals to treat COVID-19 with recovered patient’s blood

Ostrosky, also an infectious disease doctor at Memorial Hermann, said he expects UTHealth will finish enrollment of patients by the end of the year. It expects to supply about 400 of the trial’s 1,300 patients.

The plasma is being provided by the New York Blood Center.

At the same time, UTHealth and Baylor are both participating in randomized trials to determine if the therapy can be used in outpatient settings to prevent the onset of the disease in uninfected people exposed to a COVID-positive patient and the progression of the disease in people experiencing mild to moderate symptoms but not having sought hospitalization.

Both institutions have just begun enrolling patients in both those trials, which are led by Johns Hopkins University researchers.

It is unclear if the FDA will wait on the results of the randomized trials, not expected until early next year, before approving emergency use of the therapy. The Times quoted H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, saying Collins, Fauci and he “are pretty aligned on the importance of robust data through randomized control trials and that a pandemic does not change that.”

But an emergency approval could still be issued in the near future, Lane also told the Times.

Methodist’s Jones asked why there couldn’t be both randomized studies and expanded emergency use.

He acknowledged the concern that the availability of the sure thing at some hospitals might make it hard to recruit patients at hospitals where they could just as easily get a placebo, but said he thinks “there are enough patients to do both” and that the FDA “needs to balance the health needs of those not in trials.”

todd.ackerman@chron.com



Source link