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

Dakota15

Dakota15

Senior Member (Voting Rights)
Contagion Live: 'Remote Long COVID Trial to Evaluate Repurposed Drug Across US’

'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.'

'The fully remote Long Covid Treatment Trial will enroll 1,000 U.S. participants to evaluate a repurposed drug for Long COVID treatment.’

'In an email interview with Contagion, Julia Moore Vogel, PhD, co-principal investigator of LoCITT, explained the trial design and goals.’
 
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@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:

ContagionLive said:
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.”
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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.
 
Jonathan Edwards said:
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.
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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?
 
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thesicktimes.org

We need more at-home clinical trials for Long COVID. Here’s how we designed the largest one yet. - The Sick Times

We are now recruiting for the Long COVID Treatment Trial-Tirzepatide (LoCITT-T), which participants can complete entirely from bed.
thesicktimes.org thesicktimes.org

AI Summary:
We Need More At-Home Clinical Trials for Long COVID
How the LoCITT-T study aims to make research more inclusive

Out of hundreds of Long COVID trials, only two have been fully accessible from home. This excludes many patients who are housebound or too ill to travel, creating biased results and slowing scientific progress. Julia Moore Vogel and her team at Scripps Research developed the Long COVID Treatment Trial–Tirzepatide (LoCITT-T) to change this.

The trial can be completed entirely from home, even by bedbound participants. Communication with study staff happens through email, phone, or video calls, and caregivers may assist. The first treatment being tested is tirzepatide (Zepbound), a drug initially developed for weight loss that has strong anti-inflammatory effects. Researchers believe it might reduce neuroinflammation seen in Long COVID. The study is double-blind and placebo-controlled, designed to produce reliable data about the drug’s impact.

Participants self-administer injections under nurse supervision via video and track their sleep, activity, and weight using Garmin devices and smart scales provided by the study. Some also collect blood samples themselves with nearly painless microneedle devices. These samples allow for both standard and exploratory lab analyses to observe biological changes over time.

Feedback from severely ill people was crucial in designing a study that truly includes those who are often left out. Vogel, who has Long COVID herself, stresses that patient input helps reduce burdens like screen time and unnecessary data collection.

LoCITT-T builds on previous research — notably the Long COVID Wearable Study, which involved over 1,000 participants and showed that more than a quarter were likely housebound. With a target of 1,000 participants, LoCITT-T is set to be the largest Long COVID trial to date. Vogel advocates for expanding at-home digital trials to ensure equitable access and faster progress toward effective treatments.
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I think this sort of model can be good.

More on the trial here. It's open to people with Long Covid in the US. Participants get access to the drug, you get an activity monitor to keep, some amazon gift vouchers for completing followup surveys. A lot of personal data is required to be provided though.

I'm not sure how you could effectively blind a trial of tirzepatide, a GLP-1 drug. I'm pretty sure people will quickly know if they are on the drug or not. Good that they are tracking objective outcomes, but, given the lack of effective blinding, activity will need to be tracked for a long time. It looks as though the study runs for a year, which, if monitoring is done for that time, is good.
 
I’m glad someone is thinking about how to bring the trial to the patient rather than vice versa. Most studies still seem to wildly underestimate the toll it takes to get to the clinic. If they even think of it at all.

It’s good they’ve even thought of ways to get the patient to collect their own blood rather than having to get a phlebotomist come to the house.

I hope it goes well.
 
I noticed that the article in The Sick Times pointed to this definition of ME from Long Covid Justice:

What is myalgic encephalomyelitis?

It refers to the illness as ME* (with an asterisk) and has this section at the end:

Long Covid Justice said:
*ME is sometimes conflated with chronic fatigue syndrome (CFS). ME is a more specific term for the disease characterized by PEM/PENE, while chronic fatigue syndrome (CFS) can refer to a less specific set of signs and symptoms that may not include PEM/PENE. This can lead to uninformed providers prescribing harmful exercise therapies to people with PEM/PENE.
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I know things in the USA (CDC, NIH) are a terrible mess right now, but the CDC definition for ME/CFS has required PEM since shortly after the 2015 IOM report. That ME/CFS definition is still on the CDC website.

CDC diagnosis web page

CDC handout: What are ME/CFS symptoms?

Anyway, I just thought I'd pass on this info. I haven't seen many "ME is not CFS" or "ME is not ME/CFS" statements lately so I was a bit confused to see this.

EDIT: After I posted this I noticed that there are a lot of links they include at the end which use the term ME/CFS, including one going to the CDC. So maybe this is not a big issue for them after all.
 
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