Kaila Trawitzki was diagnosed with long COVID in November 2020 and has never recovered since. The software engineering representative from Sacramento, California, said her persistent symptoms, as well as the burden and threat of travel, make on-site clinical trials maximal. out of 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 instead of in-person, she immediately signed up. “Knowing that I could do it from home was really nice to me,” 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 can lead to greater participation and accelerate the progression of much-needed new treatments for others with long COVID.
Decentralized clinical trials (DCTs), in which studies are conducted outside of 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, eliminate the threat of acute COVID reinfection, publicize patient diversity, and lay the groundwork for how such trials (for long COVID and other 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.
The 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 performed at a facility near their home. After the examination, surveys were sent 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). . ) Rehearsal.
“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’s much less burdensome for patients, especially those who are homebound or bedridden, and there’s no need to make arrangements. “
This more streamlined trial also reduces inefficiencies related to more than one educational site participating 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 leading the study.
“The more coordination is required between control sites, the more inefficiency and friction there is, leading to more expense and delays,” Krumholz said. “You have more control over how everything works when everything is deployed centrally and deployed decentrally through a single site.
This is also helpful because many long COVID patients are afraid of getting reinfected, Carolyn Bramante, MD, MPH, an assistant professor of medicine at the University of Minnesota Medical School, whose studies focus on interventions conducted remotely, told Minneapolis.
“It is stressful for patients involved in on-site trials because of the fear of reinfection from being in a facility with patients in poor health, which can be a higher risk environment,” Bramante said.
Cindy Mahler, 49, an aerospace engineer founded in the Houston area, had COVID for a long time after a severe bout of acute COVID in March 2020. His symptoms worsened after a reinfection in January 2022. She enrolled in the Yale essay in February, attracted by the fact that it wouldn’t 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 threat of cardiac, pulmonary or neurological headaches in long COVID patients is greater with reinfection with COVID-19.
The Yale study also reached rural communities and participants who probably wouldn’t have had to do such trials before, Yale biologist Iwasaki said.
The hope is that some of the key barriers, such as fees and absences from work, that make it difficult for those underrepresented teams to enroll will be eliminated when testing is conducted remotely.
The lack of diversity in long-term COVID clinical trials has been a fear among researchers from the beginning, because it is difficult to have forged knowledge about a remedy if it has not been tested in a giant variety of people. A December 2022 article 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 perform DCTs, laboratories will be able to transfer the style to all types of studies.
“We created a decentralized test across the country under careful compliance with the rules,” Krumholz said.
Compliance is vital because if the knowledge does not meet the requirements of the U. S. Food and Drug Administration, it will be necessary to comply with the requirements of the U. S. Food and Drug Administration. In the U. S. , they cannot be used through pharmaceutical corporations seeking firm approval for new treatments. Krumholz said this will open the door to many more experiments so that we can be informed faster and be able to better treat patients with long COVID.
“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 worsened after the trial, they still don’t know whether they received Paxlovid or a placebo and likely won’t know until next month. But one thing they are sure of is that the Yale study has given them hope: hope that they are or will be better, and hope for 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 to conduct clinical trials is unrealistic.
“I really felt like I supported the study,” Trawitzki said.
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