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NIH halts trial of Covid plasma remedy after researchers discovered no profit

NIH halts trial of Covid plasma treatment after researchers found no benefit

Convalescent plasma from a patient with recovered coronavirus disease (COVID-19) is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington on April 17, 2020.

Lindsey Wasson | Reuters

The National Institutes of Health announced Tuesday that they had abandoned a study testing convalescent plasma in patients with mild to moderate Covid-19 symptoms after an independent panel of experts concluded it was unlikely to be beneficial.

The independent data and safety watchdog met on February 25 to review the data and found that while plasma treatment did no harm, it was unlikely to be of benefit to this patient population, the NIH said in a press release. After the meeting, the DSMB recommended that the NIH no longer enroll new patients in the study, the agency said.

Scientists and public health officials had previously said they were skeptical that convalescent plasma would be an effective treatment for patients with Covid, even after the Food and Drug Administration issued emergency approval for the treatment in August and former President Donald Trump said it was ” Breakthrough “denounced. “

At the time, Dr. Scott Gottlieb, a former FDA commissioner, said the treatment could help patients but “doesn’t look like a home run”. He agreed that convalescent plasma “certainly” met the standard for an emergency permit “in the context of a public health emergency.”

The plasma, taken from patients who have recovered from Covid-19 and who have developed antibodies to the virus, is infused into sick patients. Scientists had hoped it would help boost immune systems in these patients to fight the virus.

In January, REMAP-CAP, an international clinical trial investigating possible treatments for Covid, discontinued the study testing convalescent blood plasma after the study’s examiners found no benefit. The decision by REMAP-CAP was made after an initial analysis of more than 900 critically ill study participants in the intensive care unit showed that treatment with the product did not noticeably improve the health of the patients.

The NIH study was conducted in 47 US hospitals emergency departments and had 511 of the 900 participant recruitment targets enrolled. After study participants received either the plasma or a placebo, the researchers tracked whether participants needed additional emergency or urgent treatment, had to be hospitalized, or died within 15 days of the start of the study.

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42 Individuals in West Virginia Mistakenly Given Virus Remedy As a substitute of Vaccine

42 People in West Virginia Mistakenly Given Virus Treatment Instead of Vaccine

42 people in Boone County, southwest West Virginia, who were due to be given the coronavirus vaccine Wednesday, were instead mistakenly injected with experimental monoclonal antibody treatment, the West Virginia National Guard said Thursday.

None of the 42 recipients have developed any adverse effects to date, the guard said in a statement. The guard who directs the state’s vaccine distribution efforts described the flaw as a “collapse of the process.”

The experimental treatment, a cocktail of antibodies from Regeneron, is the same that President Trump received when he was hospitalized with Covid-19 in November. It is intended to be given as an intravenous infusion, not a direct injection like the vaccine.

Maj. Gen. James Hoyer, the West Virginia National Guard’s adjutant general, said the mix-up appeared to have occurred during the delivery of a shipment of the Regeneron cocktail to a distribution hub where the vials were placed among the supplies of the Moderna vaccine. The hub staff then apparently included the treatment vials in a vaccine shipment to Boone County.

General Hoyer attributed the situation to “a few human errors” and said the guard acted quickly once they realized what had happened. “We have found a problem, we fix it and we are making progress,” he said on Thursday in a radio interview.

No other shipments of the vaccine were affected, the guard said in a statement.

Vials for the treatment and vaccine look somewhat similar but are clearly labeled, as are the boxes they are in. Both are kept refrigerated before use.

The mistake came at a time when record numbers of hospitalizations across the country signaled a greater need than ever for the scarce and expensive antibody treatments, even though some supplies across the country are being kept unused in refrigerators.

Officials in West Virginia reported 1,109 new coronavirus cases and 20 new deaths Thursday. There have been at least 85,334 cases and 1,338 deaths in the state since the pandemic began, according to a database from the New York Times.

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West Virginia mistakenly provides 42 individuals Regeneron IV Covid therapy as a substitute of vaccine shot

West Virginia mistakenly gives 42 people Regeneron IV Covid treatment instead of vaccine shot

A pharmacist dilutes the Pfizer COVID-19 vaccine as he prepares it for administration to staff and residents at Goodwin House Bailey’s Crossroads, a senior community in Falls Church, Virginia, on December 30, 2020.

Brendan Smialowski | AFP | Getty Images

Dozens of people in West Virginia were mistakenly given Regeneron’s Covid-19 antibodies instead of the Moderna vaccine, the West Virginia National Guard said Thursday.

According to the state’s National Guard, 42 people received the intravenous treatment at a Boone County Department of Health vaccination clinic. The National Guard said it learned of the mistake on Wednesday.

Everyone who received the antibody treatment instead of the vaccine, which is given through a shot in the arm, has been contacted, Julie Miller, a Boone County Health Department administrator, told CNBC via email. She added, “We don’t think there is any risk of harm.”

Regeneron’s monoclonal antibody treatment, which must be given via an IV drip, is seen as a promising treatment for Covid-19 – especially if given early in the course of the infection. But the West Virginia mix-up is just one example of the confusion in the rush to distribute the vaccine to tens of millions of people. The rollout was slower than expected and was characterized by logistical challenges.

“It was determined that this was an isolated incident,” Miller said. “All those affected will be offered the COVID-19 vaccine today.”

She said the health department will work closely with the state National Guard and the Department of Health and Human Resources to review their policies and procedures.

Miller did not provide details on what caused the mix-up.

Representatives from the West Virginia National Guard and the West Virginia Governor’s Office did not respond to CNBC’s request for further comment on the occurrence of the error.

Maj. Gen. James Hoyer, adjutant general of the West Virginia National Guard, said in a statement that his forces “acted immediately” to correct the mistake as soon as they found out what happened. “We immediately reviewed and strengthened our logs to improve our sales process and prevent this from happening again,” he said in a statement.

He added that the state will continue to promote the vaccine “to save more lives every day”.

Dr. Clay Marsh, the state’s Covid-19 tsar, noted in a statement that the Regeneron treatment mistakenly given in place of the vaccine is the same product “that was given to President Trump when he became infected”.

“Although this injection is not harmful, it has replaced the vaccine,” he said. “However, this event provides an important opportunity for our leadership team to review and improve the safety and vaccination process for every West Virginian.”