Stanford Medicine’s long COVID study explodes because of unmasked staff


A clinical trial conducted by Stanford Medicine to study the use of paxlovid to combat the novel coronavirus was shocked last week when it was revealed that staff had stopped masking around paxlovid. I was. Several patients took to social media and said they quit the study as a result.

Masking is no longer mandated by the California Department of Public Health and the Santa Clara County Public Health Department where the tests were conducted. Nonetheless, patients expected clinical trial staff to continue wearing masks to reduce the likelihood of reinfection and exposure to other infections.

“I knew that the mask mandate was dropped, but I naively assumed that staff who interacted with COVID patients for a long time still wore masks,” he said. Olivia H., a trial patient who requested to refrain, told The Daily The Beast. “I was really disappointed when the research assistants and nurses walked into my room without masks on.”

The patient strike was first revealed by a user whose wife was in the trial in a Reddit post dated April 28 (her husband confirmed the story directly to The Daily Beast). A second participant confirmed to The Daily Beast via her Twitter that he stopped the trial because of unmasked staff. His third person on Reddit did not confirm whether they belonged to his Paxlovid trial, but claimed he had also dropped out of the Stanford clinical trial due to fear of masking. Attempts to do so have failed.

When contacted by The Daily Beast, Stanford Medicine only confirmed that one patient in the Paxlovid trial had withdrawn due to masking concerns.

“It is frankly abhorrent and selfish behavior that not only demonstrates a complete lack of respect and understanding for the disease in question,” wrote one Reddit user. “We’ve traveled months and hundreds of miles to participate in their research and provide data on disease. This is what they think of us.”

Since 2019, more than 16 million Americans have had long-lasting COVID. Symptoms can last for months or years, including chronic fatigue and exhaustion, sensitivity to light, susceptibility to further infections, problems with organs such as the lungs and stomach, and cognitive impairment. .

Scientists are trying to figure out how long COVID lasts, and there is currently no cure or breakthrough cure. Stanford’s clinical trial is just his one of many studies looking for some kind of hope. Paxlovid, an antiviral drug consisting of nilmatrelvir and ritonavir, was effective in preventing her mild COVID infection from developing into severe illness requiring hospitalization.

In this trial, researchers recruited 200 long-term COVID-19 patients, gave them 15 days of paxlobid or placebo, and then measured changes in symptoms over 15 weeks.

When participants entered the trial, medical staff wore masks regularly as required. However, on April 3, the power of attorney was withdrawn. Study participants felt uneasy and many felt betrayed in recent weeks as the support staff who helped them with the exam stopped wearing them.

Despite her concerns, Olivia H. stayed with the trial because her last study visit was on April 24th. “All staff involved in clinical trials should understand that long-term COVID patients are fundamentally immunocompromised and take necessary steps to prevent the meager health we have left from getting worse. “Previous research suggests that repeated COVID infections can lead to worse health outcomes, including increased risk of organ failure and hospitalization and death.” I’m here.

The trial’s lead investigators, Linda Genn and Apinder Singh, did not respond to requests for interviews or comment.When contacted by The Daily Beast, Lisa Kim, senior manager of media relations at Stanford Medicine, said: said to According to the California Department of Public Health and the Santa Clara County Public Health Department, wearing masks in all clinical settings is no longer required, but recommended. We will continue to recommend and support masking and make masks available to healthcare workers, patients, and visitors to healthcare facilities. Kim said whether clinical trial staff notified patients in advance that they might not be wearing masks, concerns over the safety of COVID-19 reinfection, or the future of the trial. I didn’t answer the question.

So far, Stanford’s response has failed to convince patients that their concerns are being taken seriously. In a tweet posted on April 30, Jeffrey Bien, an oncologist at Stanford University School of Medicine, said: ridiculed the patient’s safety concerns as he walked away On April 30th, he wrote, “If you’re not careful, you’re going to disrupt the top-secret, super-duplex long-term Covid community.” (Bien did not respond to a request for comment.)

There were already signs that staff and Stanford Medicine were ready to take the masks off, said Yvonne Moldanado, an expert in pediatric infectious diseases at Stanford. Presentation to medical personnel April 13th.

Still, it’s particularly noteworthy to see masks peeling off around patients being specifically treated for COVID. If you don’t care about patient safety enough to implement simple COVID-19 mitigation measures, should patients trust that the rest of the trial will be safe?” Neurologist at Stony Brook University School of Medicine Lauren Stiles, president of advocacy group Dysautonomia International, told the Daily Beast. He added that he was hesitant to raise safety concerns.

It seems almost logical to me that long-term clinical trials for COVID should protect long-standing COVID patients from the virus that caused the disease in the first place.

Olivia H.

Stiles is also a patient representative for NIH RECOVER, another group of long-term COVID clinical trials conducted by the National Institutes of Health. “We don’t know if RECOVER requires masking for research personnel interacting with COVID patients, but like other patient advocacy groups, we are asking for it,” Stiles said. Even if we don’t care about protecting patients, we need to be careful not to confuse trial data with new infections mid-study.”

The prolonged COVID has strained families and romantic relationships, and has prevented up to 4 million Americans from returning to full-time work. Many patients hope that clinical trials like Paxlovid’s can provide desperately needed solutions. But they don’t want to risk reinfection.

“I was (and still am) very ill, but enrolling in a trial because it alleviates or eliminates some of my symptoms and gives me the chance to participate in a trial that millions of COVID patients want. I was thrilled with it,” said Olivia H. “It seems almost logical to me that a long COVID trial should protect her long-term COVID patient from the virus that caused the disease in the first place.”





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