No Masks in Long COVID Study? Participants Aren't Happy

Participants in a long COVID clinical trial at Stanford University in California have raised concerns that some investigators there are not wearing masks during clinic visits, putting them at risk.

The issue was first highlighted in a Reddit post on r/covidlonghaulers, where an anonymous poster said he or she and their wife walked out and quit the study last week because "researchers running the long COVID Paxlovid study have stopped masking while tending to long COVID participants."

That commenter, who has not returned a request for comment from MedPage Today, called the lack of masks "abhorrent, selfish behavior" that shows a "lack of regard for the safety and well-being of their patients/subjects."

Ezra Spier, a long COVID patient who spoke during an FDA hearing on long COVID last month, is also a participant in the trial, which is known as the Paxlovid for Treatment of Long COVID (STOP-PASC) trial and is supported by Pfizer.

Spier said he "share[s] the concerns of the person in the original post, but I haven't walked out of the study."

"I did share my concerns with the study team, and they responded directly to me," Spier said. "I'm satisfied with their response and plan to remain in the study."

Lead investigators on the study are Linda Geng, MD, PhD, and Upinder Singh, MD. They did not respond to a request for comment; but in an emailed statement, a spokesperson for Stanford Health Care School of Medicine said the organization "has a record of offering patients high-quality care in a safe setting. Our clinical trials are an important way to conduct research that helps advance new treatments for our patients."

"Across all of our Stanford Medicine clinical facilities, the safety of our patients, families and staff continues to be our highest priority," the statement continued. "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 healthcare workers, patients, and visitors at our care facilities."

Spier explained that long COVID patients are concerned about reinfection and how that might impact their long COVID and their health. They have generally been unhappy with a lack of masking in healthcare settings.

"The issue of masking in healthcare settings is of huge importance to me," Spier told MedPage Today in an email. "For instance, I had to get a brain MRI last week to rule out some potential causes of my severe neurological symptoms. Patients can't wear an N95 mask during an MRI because they contain metal, so I had to remove it and use the simple surgical mask they provided. But because my healthcare facility ... has ended its mask mandate, there was a heightened risk of me contracting illness (whether COVID or something else). This is a huge problem for people who are immunocompromised or who risk significant long COVID symptom exacerbation."

While the risks of reinfection or getting infected with another disease while suffering from long COVID haven't been enumerated, many physicians say these patients' concerns should be accommodated, particularly out of professional courtesy.

Spier noted that some physicians on Twitter took a careless attitude toward participants' concerns. Such comments "get in the way of us accessing care," Spier said. "One of the biggest challenges that folks with long COVID experience is medical gaslighting and comments claiming that long COVID is just in our heads."

The Reddit commenter alleged that in addition to putting participants' health at risk, changing the conditions of the study could alter its outcomes.

He or she questioned whether investigators "risk invalidating the entire project and its data by suddenly increasing the odds of reinfecting their participants and negatively changing the course of their health."

When Harlan Krumholz, MD, of Yale University in New Haven, Connecticut, who runs a similar but separate trial of nirmatrelvir-ritonavir (Paxlovid) for long COVID with colleague Akiko Iwasaki, PhD, was asked for comment on the issue, he said he was "sorry to hear that [the Stanford researchers] are in the spotlight like this."

"They are good investigators trying to get answers," Krumholz said. "But I also understand that people with long COVID are really worried ... and many want to be very careful."

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