Recovering plasma from a recovered coronavirus disease (COVID-19) patient is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington, April 17, 2020.
Lindsey Wasson | Reuters
The National Institutes of Health said Tuesday it was discontinuing a trial testing restorative plasma in patients with mild to moderate Covid-19 symptoms after an independent group of experts concluded it was unlikely to be beneficial.
The Independent Data and Safeguards Board met on Feb. 25 to review the data and determined that while the plasma treatment caused no harm, it was unlikely to benefit this group of patients, the NIH said in a press release. After the meeting, the DSMB advised that the NIH stop enrolling new patients for the study, the agency said.
Scientists and public health officials had previously said they were skeptical that restorative plasma was an effective treatment for patients with Covid, even after the Food and Drug Administration issued an emergency permit for the treatment in August and former President Donald Trump considered it a “ breakthrough ” called. . “
At the time, Dr. Scott Gottlieb, a former FDA commissioner, said the treatment might help patients, but it “doesn’t look like a home run.” He agreed that restorative plasma “certainly” met the standard for an emergency use approval “in the context of a public health emergency.”
The plasma, collected from patients who have recovered from Covid-19 and developed antibodies to the virus, is administered to sick patients. Scientists had hoped it would help those patients’ immune systems fight off the virus.
In January, REMAP-CAP, an international clinical trial investigating potential treatments for Covid, stopped testing restorative blood plasma after the researchers found no benefit. The REMAP-CAP’s decision came after an initial analysis of more than 900 critically ill ICU subjects, which showed that treatment with the product did not significantly improve patient health.
The NIH study was conducted in 47 hospital emergency departments in the United States and enrolled 511 of the 900 enrollment target participants. After the study participants received the plasma or a placebo, the researchers kept track of whether the participants needed to seek further emergency or emergency care, be hospitalized, or died within 15 days of starting the trial.