LoCITT: Remote Long COVID Trial to Evaluate Repurposed Drug Across US

[Sasha]

@Dakota15 posted about this trial on another thread but I think it's a very interesting example of an approach that could be applied to ME/CFS and worth discussing:

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. [...]

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? [...]

Vogel: [...] We aim to contribute to the best practices for conducting accessible, remote trials, including validating the use of wearables to collect outcome data.”

 

[Jonathan Edwards]

The only problem I see with this is that patients may not get a full clinical and diagnostic assessment first hand before being enrolled. They may have something else wrong with them and die through not being treated because they are on a trial instead. Obviously it is not quite as simple as that but I would not want to enrol anyone into a trial withut being sure what was wrong with them.

"Long Covid" is perhaps particularly tricky here because it is so vague. Anyone who falls ill for any reason after having had Covid may get diagnosed as Long Covid.

It might be usable for ME/CFS but at the moment the problem for ME/CFS is that nobody can think of a drug to try. If they had then proposals would have been set up. A proposal went in for naltrexone that did not get funded but I doubt many people have great hopes for that. Rituximab proposals were submitted and in the end the Norwegians followed that through. Not much else has surfaced.

If there was a candidate drug something like this might be workable but I would like to think patients were fully assessed before recruiting.

 

[Sasha]

The only problem I see with this is that patients may not get a full clinical and diagnostic assessment first hand before being enrolled. They may have something else wrong with them and die through not being treated because they are on a trial instead. Obviously it is not quite as simple as that but I would not want to enrol anyone into a trial withut being sure what was wrong with them.

This is the kind of thing I think it's worth thinking through. I'd been wondering about what monitoring might be necessary for safety and whether it would involve GPs.

What sort of specialist would be needed to do a full pre-trial assessment, or could GPs do it?

 

[hotblack]

What sort of specialist would be needed to do a full pre-trial assessment, or could GPs do it?

It’s my big concern for any drug trials. We don’t have any drs that can look after us now so trusting them to do in a trial seems… a hurdle we need to fix.

 

[EndME]

There have already been quite a few decentralized trials for Long-Covid with a similar setup to the one above. The Paxlovid study by Iwasaki had a similar setup. I agree that Long-Covid diagnosis will make things very tricky, if not meaningless, if these things aren't taken care of very meticulously.