Kaila Trawitzki was diagnosed with long COVID in November 2020 and has never recovered since. The software engineering representative from Sacramento, California, said her lingering symptoms, coupled with the burden and threat of travel, make on-site clinical trials off-limits.
But last year, when scientists at Yale University in New Haven, Connecticut, began recruiting patients for a lengthy COVID treatment trial that would be conducted remotely rather than in-person, she immediately signed up. “The house really drew me in,” Trawitzki said.
In the U. S. , as many as 17 million people currently have long COVID, but experts say trials have been slow to recruit patients, in part because getting to the core areas of trials can be expensive and complicated for people suffering from fatigue, nausea and shortness of breath. breath problems, gastrointestinal problems, and more. Remote trials that allow participants to take most, if not all, experimental treatments at home, allow even the sickest patients with long COVID to participate.
Yale researchers say remote trials could lead to greater participation and boost the progress of much-needed new treatments for other people with long COVID.
Decentralized clinical trials (DCTs), in which studies are conducted outdoors from an educational site, have become more popular during the COVID-19 pandemic, when travel restrictions and physical distancing made on-site studies difficult. Not to mention the technologies and the ability to The percentage of knowledge is improving.
DCTs are more effective, remove the threat of acute COVID reinfection, publicize patient diversity, and lay the groundwork for how such trials (for COVID and other protracted COVID situations) will be conducted in the future.
The Yale study recruited 100 long COVID patients across the country to determine whether 15 days of Paxlovid antiviral treatment would improve their symptoms. The drug arrived to patients in the mail and they didn’t know if their drug was Paxlovid or a placebo.
Patients took the tested drug twice a day for 15 days and were asked to record their symptoms at night. A test representative also visited the patient’s home to collect and record blood tests, and some patients had blood tests done at a facility near their home. After the examination, surveys were sent out periodically to check patients’ symptoms.
Remote clinical trials like this one are for patients severely affected by long COVID, said Akiko Iwasaki, PhD, an immunologist and molecular biologist at Yale School of Medicine, in New Haven, Connecticut, who worked on the Long COVID Remote (PAX LC). ) Essay.
“Many of them are not healthy enough to go to a clinic, which gives them the freedom to enroll in a trial,” Iwasaki said. “It is much less burdensome for patients, especially those who are homebound or bedridden, and there is no need to make arrangements. “
This more streamlined trial also reduces the inefficiencies of involving more than one educational center in a clinical trial, said Harlan Krumholz, MD, a cardiologist at Yale School of Medicine and principal investigator of the PAX LC trial. Yale is the educational center that will lead the study.
“The more coordination that is required between control sites, the more inefficiency and friction there is, resulting in more expense and delays,” Krumholz said. “You have more control over how everything works when everything is implemented centrally and implemented decentrally through a single site.
This is also helpful because many long COVID patients are afraid of getting reinfected, said Carolyn Bramante, MD, MPH, an assistant professor of medicine at the University of Minnesota Medical School, Minneapolis, whose studies focus on interventions conducted remotely.
“It’s stressful for patients involved in on-site trials because of the threat of reinfection from being in use in a facility with patients in poor health, which can be a higher-threat environment,” Bramante said.
Cindy Mahler, 49, an aerospace engineer based in the Houston area, had long-term COVID after a severe episode of acute COVID in March 2020. Her symptoms worsened after reinfection in January 2022. She enrolled in the Yale trial in February, attracted by the fact that it would not require her to travel.
“I live my life to protect my immune system,” Mahler said. “I don’t need to be in poor health for anything because I need to keep progressing and getting stronger. “
Mahler’s considerations are well founded, according to an August 2023 study published in the International Journal of Molecular Sciences. He showed that the risk of cardiac, pulmonary or neurological headaches in long COVID patients increases with COVID-19 reinfection.
The Yale study also reached rural communities and participants who might not have had to do such trials before, said Iwasaki, the Yale biologist.
The hope is that some of the key barriers, such as job titles and absences from work, that make it difficult for those underrepresented teams to sign up, will be removed when testing remotely.
The lack of diversity in long-term COVID clinical trials has been a fear among researchers from the beginning, as it’s tricky to forge knowledge about a remedy if it hasn’t been tested on a wide variety of people. A December 2022 paper published in JAMA Internal Medicine found that female, Asian, Black, and Hispanic participants were underrepresented in COVID treatment trials.
In addition, it is hoped that with a greater understanding of how to execute DCTs, laboratories will be able to translate the style to a variety of studios.
“We created a decentralized test across the country for careful scrutiny of regulatory compliance,” Krumholz said.
Compliance is vital because if the knowledge does not meet the standards of the U. S. Food and Drug Administration, it will be necessary to comply with the standards of the U. S. Food and Drug Administration. In the U. S. , it cannot be used through pharmaceutical corporations seeking firm approval for new remedies. Array Krumholz said this will open the door to many more experiments so we can be informed faster and be better able to treat long COVID patients.
“It’s like Kitty Hawk: It flies, and now we have to fly fleets of those planes,” he said.
Trawitzki and Mahler felt their symptoms improved after the trial, they still don’t know if they took Paxlovid or a placebo and likely won’t know until next month. But one thing they are sure of is that the Yale study gave them hope. I hope they get better or better, and I hope the formula as a whole.
For the first time, they felt like they were being heard and that, despite everything, other people understood that, especially in this patient population, traveling across the country for clinical trials is not realistic.
“I really felt like I supported the study,” Trawitzki said.
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