A clinical trial run by Stanford Medicine to study the use of Paxlovid to fight long COVID was rocked last week, when it was revealed that staff stopped masking around them. Multiple patients took to social media to say they had left the study as a result.
Masking is no longer mandated by the California Department of Public Health and Santa Clara County Public Health, where the trial was held. Nonetheless, patients expected clinical trial staff to continue masking around to reduce the chances of reinfection, or exposure to other infectious diseases.
“I knew that mask mandates were dropped, but I naively assumed that staff interacting with long COVID patients would still wear masks,” Olivia H., a patient in the trial who requested her full last name be withheld for privacy reasons, told The Daily Beast. “I was really disappointed when the research assistant and nurse entered my room without a mask on.”
The walkout of the patients was first revealed on a Reddit post dated April 28, by a user whose wife was part of the trial (the husband confirmed the story directly with The Daily Beast). A second participant confirmed to The Daily Beast via Twitter they had left the trial because of unmasked staff. A third person on Reddit claimed they had also dropped out of a Stanford clinical trial because of fears over masking, though they did not confirm whether they belonged to the Paxlovid trial. Attempts to interview the participants were unsuccessful.
When reached by The Daily Beast, Stanford Medicine would only confirm that one patient in the Paxlovid trial pulled their participation due to masking concerns.
“It’s frankly abhorrent, selfish behavior, and not only does it demonstrate a complete lack of regard and understanding for the illness in question,” the Reddit user wrote. “We’ve been traveling hundreds of miles for months in order to try to participate in their study and provide them with data about the illness, and this is what they think of us.”
More than 16 million Americans have developed long COVID since 2019. Symptoms, which can last for months or even years, can include chronic fatigue and exhaustion, light sensitivity, susceptibility to further infection, issues with organs like the lungs and stomach, and cognitive impairment.
Scientists are still trying to unravel how long COVID manifests, and there are currently no cures or breakthrough treatments. The Stanford clinical trial is just the one of many looking for some kind of hope. Paxlovid—an antiviral medication consisting of nirmatrelvir and ritonavir—was effective in preventing mild COVID infections from evolving into severe disease that would require hospitalization.
For the trial, researchers recruited 200 people with long COVID and prescribed each with a 15-day course of Paxlovid or placebo, followed by check ups over the course of 15 weeks to measure changes in symptoms.
When participants began the trial, the medical staff regularly wore masks per requirements. On April 3, however, the mandate was dropped. Participants in the study became alarmed in recent weeks as support staff assisting the trial have stopped wearing them, leaving many to feel betrayed.
Though alarmed, Olivia H. didn’t walk off from the trial since her final study visit was April 24. But the lack of protections for other participants have undermined her trust in the medical staff and researchers behind the study. “I would expect that all staff involved in the trial would understand that long COVID patients are fundamentally immunocompromised, and they would take necessary steps to protect what little health we have left from further deteriorating,” she said. Previous studies have suggested that repeated COVID infections can lead to worsened health conditions, including organ failure and increased risk for hospitalization and death.
The lead investigators of the trial, Linda Geng and Upinder Singh, did not respond to requests for interviews or comment. When reached by The Daily Beast, Lisa Kim, senior manager of media relations at Stanford Medicine, provided the statement: “Across all of our Stanford Medicine clinical facilities, the safety of our patients, families and staff continues to be our highest priority. In accordance with the California Department of Public Health and Santa Clara County Public Health, wearing masks in all clinical settings is no longer mandated, but recommended. We continue to recommend and support masking and make masks available for health care workers, patients and visitors at our care facilities.” Kim did not answer specific questions about whether patients were informed beforehand that clinical trial staff may not be masking, safety concerns of COVID-19 reinfection, or the future of the trial.
So far, Stanford’s response has not left patients feeling confident that their concerns are being taken seriously—at a time when long COVID isn’t fully understood and sometimes even dismissed by doctors and members of the public. In a tweet posted April 30, Stanford Medicine oncologist Jeffrey Bien mocked the safety concerns of the patients who walked off on April 30, writing “Be careful or you’ll upset the super secret ultra-double-long-Covid community.” (Bien did not respond to a request for comment.))
There were already signs that the staff and Stanford Medicine were ready to unmask: One pediatric infectious disease expert at Stanford, Yvonne Moldanado “celebrated” the lifting of mask mandates in a presentation to medical colleagues on April 13.
Still, it’s especially notable to see unmasking around patients who are being specifically attended to for long COVID. “If researchers don’t care enough about patient safety to implement the simplest of COVID-19 mitigation measures, like wearing a mask around patients, why should patients trust the rest of the trial is safe?” Lauren Stiles, a neurologist at Stony Brook University School of Medicine and president of advocacy organization Dysautonomia International, told The Daily Beast. She added that patients are hesitant to raise safety concerns during these trials publicly for fear of losing access to medical care.
“To me it almost seems logical, that long COVID patients in a long COVID trial need to be protected from the virus that triggered their illness in the first place.”
— Olivia H.
Stiles is also a patient representative for NIH RECOVER, another group of long COVID clinical trials run by the National Institutes of Health. “I don’t know if RECOVER will require masking for study personnel interacting with long COVID patients, but we have asked for this, as have other patient advocacy organizations,” Stiles said. “Even if researchers don’t care about protecting their staff, they should care about protecting their patients and not muddying their trial data with new infections in the middle of a trial.”
Long COVID has strained family and romantic relationships and left up to four million Americans unable to return to work full-time. Many patients pin great hopes that clinicals trials like the Paxlovid one could provide a desperately needed solution. But they also don’t want to risk reinfection.
“I was (and still am) severely ill, and was excited to enroll in the trial as it would provide me with the chance to ease or eliminate some of my symptoms and participate in a trial that millions of long COVID sufferers are hopeful about,” Olivia H. said. “To me it almost seems logical, that long COVID patients in a long COVID trial need to be protected from the virus that triggered their illness in the first place.”
