Patients with Long COVID can now sign up to receive notifications about an upcoming fully remote clinical trial led by Scripps Research and supported by the Schmidt Initiative for Long Covid (SILC). The trial will be conducted through CareEvolution’s MyDataHelps platform, enabling participants to enroll and take part from home.1
The Long Covid Treatment Trial (LoCITT) will test the effectiveness of a repurposed drug in treating Long COVID. The study plans to enroll 1,000 participants nationwide, with all activities—including enrollment, randomization, and data collection, completed remotely. Study drugs or placebos will be mailed directly to participants, who will also receive wearable devices to monitor heart rate, sleep, and activity. This approach aims to reduce barriers to participation, particularly for patients with severe or mobility-limiting symptoms.1
In an email interview with Contagion, Julia Moore Vogel, PhD, co-principal investigator of LoCITT, explained the trial design and goals.
Contagion: What scientific criteria guided the selection of the repurposed drug candidate for the LoCITT study, and what makes it a promising option for Long COVID?
Vogel: “We selected the candidate that we think has the best chance of making a difference for people with Long COVID based on the data available at the time and complementing existing trials.”
Contagion: Given the fully remote nature of the trial, how will Scripps ensure clinical data validity and minimize variability in participant-reported outcomes and wearable device data?
Vogel: “We have intentionally designed a remote trial to ensure we can include housebound and bed bound participants - which includes about a quarter of people with Long COVID who are systematically excluded from trials that require participants to go to a specific location. The primary endpoint will be a well-validated survey and we aim to validate the use of data from wrist-worm wearables for primary endpoint use in future trials. We will be in frequent contact with participants to ensure they are well informed about the trial, taking the medication, to discuss any side effects, and provide any support they need.”
Contagion: How do you anticipate the LoCITT trial will contribute to evolving standards in clinical research for post-viral syndromes, and what would success look like, scientifically and operationally?
What You Need To Know
The fully remote Long Covid Treatment Trial will enroll 1,000 U.S. participants to evaluate a repurposed drug for Long COVID treatment.
Study design includes mailing medications, placebos, and wearable devices directly to patients, enabling participation from home.
Researchers aim to reduce barriers to clinical trial access and advance standards for decentralized Long COVID and post-viral syndrome research.
Vogel: “Operationally, success would look like meeting enrollment, retention, and adherence goals. Clinically, success would look like a meaningful reduction of Long COVID symptoms with minimal adverse events. We aim to contribute to the best practices for conducting accessible, remote trials, including validating the use of wearables to collect outcome data.”
Back in October 2024, Vogel published an analysis of Long COVID clinical trials, emphasizing the need for more rigorous, accessible, and inclusive study designs. She and her coauthors urged prioritization of pharmaceutical interventions, remote participation options, and diverse patient representation, recommendations that align closely with the goals of the upcoming LoCITT trial.2
According to the CDC, Long COVID is a chronic condition that can develop at least three months after a SARS-CoV-2 infection, affecting both adults and children. It is associated with a wide range of symptoms that may persist, recur, or worsen over time, and in some cases may result in disability. While anyone can develop Long COVID, the risk is higher among women, Hispanic and Latino individuals, older adults, those with underlying conditions, unvaccinated individuals, and patients who experienced severe illness. The CDC emphasizes that staying up to date with COVID-19 vaccination remains the best available protection, and while there is no single diagnostic test, healthcare providers can guide management through history, examination, and clinical evaluation.3
References
2.Vogel JM, Pollack B, Spier E, et al. Designing and optimizing clinical trials for long COVID. Life Sci. 2024;355:122970. doi:10.1016/j.lfs.2024.122970