Convalescent plasma from a patient with recovered coronavirus disease (COVID-19) is seen at the Bloodworks Northwest Seattle Central Donor Center during the outbreak in Seattle, Washington, on April 17, 2020.
Lindsey Wasson | Reuters
The National Institutes of Health said on Tuesday that it suspended a trial testing convalescent plasma in patients with mild to moderate symptoms of Covid-19 after an independent group of experts concluded that it was unlikely to be beneficial.
The independent data and security monitoring council met on February 25 to review the data and determine that, although plasma treatment has not caused any harm, it is unlikely to benefit this group of patients, the NIH said in a statement. After the meeting, the DSMB recommended that NIH stop enrolling new patients in the study, the agency said.
Scientists and public health officials had previously said they were skeptical. Convalescent plasma was an effective treatment for patients with Covid, even after the Food and Drug Administration issued an emergency use authorization for treatment in August and former President Donald Trump called it a “breakthrough.”
At the time, Dr. Scott Gottlieb, a former FDA commissioner, said the treatment could help patients, but “it doesn’t feel like a home run”. He agreed that convalescent plasma “certainly” met the standard for emergency use approval “in the setting of a public health emergency”.
Plasma, which is taken from patients who have recovered from Covid-19 and developed antibodies to the virus, is infused into sick patients. Scientists hoped this would help start these patients’ immune systems to fight the virus.
In January, REMAP-CAP, an international clinical trial that explores potential treatments for Covid, discontinued its study testing convalescent blood plasma after trial researchers found no benefit. The REMAP-CAP decision came after an initial analysis of more than 900 critically ill clinical trial participants in intensive care showed that treatment with the product did not significantly improve the patient’s health.
The NIH study was conducted in 47 hospital emergency departments in the United States and enrolled 511 of the target recruitment of 900 participants. After the study participants received the plasma or a placebo, the researchers tracked whether the participants needed to seek emergency or urgent care, were to be hospitalized or died within 15 days of entering the study.