LIINC Long COVID Clinical Trials

LIINC clinical trials are among the first in the world.

What Are Clinical Trials?

Clinical trials are research studies in which we test the effect of potential treatments. Sometimes these treatments are already approved for other conditions, and sometimes they are experimental. Much of our previous research has been observational, meaning we simply record and analyze participants’ specimens and symptom data without giving them a treatment or medication. Now, we have begun interventional research, including clinical trials, meaning that we are now testing medications and other treatments to see if they will improve Long COVID symptoms.

Are Clinical Trials Risky?

There is a higher risk to taking part in clinical trials compared to observational research. For example, participants may experience side effects from the treatments we are testing. However, participants are followed closely throughout the study by our incredible clinical trials team who keep participant safety at the forefront of all trials.

Am I Too Sick to Participate in Clinical Trials?

Clinical trials often require many visits which can be hard on people experiencing fatigue or post-exertional malaise. We try to make it as easy as possible for participants to be a part of the study. Yet, participation is still expected to be a greater commitment than our observational studies and participants should consider this before deciding to join. We hope to launch home-based research activities for those who are bed-/house-bound in the future.

Will a Clinical Trial Cure My Long Covid?

We hope our clinical trials may finally lead to a proven treatment for Long COVID. However, our research is highly exploratory and there is no guarantee that people will feel better from taking part in our studies. Our participants will, however, have the benefit of knowing they are contributing to an important scientific cause: defeating Long COVID.

What About the Placebo?

A gold standard in clinical trials, our studies often have a placebo group, in which participants do not receive the experimental drug but instead something equivalent to a “sugar pill,” which we know will not affect their health. This helps us understand the effects of the treatment we are testing and come to conclusions about how it worked. Usually, neither the study team nor the participants know what treatment they received until the study is over. This may affect some participants’ interest in taking part in the study.

How Do I Join a Clinical Trial With LIINC?

To have the opportunity to get involved with one of our trials, we’ll need participants to first join the LIINC study. Once participants are in LIINC, we can assess their eligibility for our trials and decide together which trials may be the best fit for them.

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Trials in Progress:

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (outSMART-LC)
In Progress, Not recruiting

outSMART-LC is a 36-person clinical trial investigating a monoclonal antibody for Long COVID symptoms. Persistent COVID-19 virus is thought to be a potential cause of Long COVID and monoclonal antibodies may be able to help the body get rid of it. Participation in the study lasts a little over 1 year.

Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)
In Progress, Recruiting

PREVAIL-LC is a 40-person trial investigating an antiviral medication called Ensitrelvir for Long COVID symptoms. Ensitrelvir shuts down the virus’s reproduction during infection and may help clear residual virus from the body, which is thought to be a potential cause of Long COVID. Participation lasts around 3 months.

REVERSE-Long COVID-19 With Baricitinib Study (REVERSE-LC)
Upcoming, Not Yet Recruiting

REVERSE-LC is a multi-site, 500+ person clinical trial exploring Baricitinib, an immunomodulator medication, to target inflammation in the body that could be contributing to Long COVID symptoms. Participation in the study lasts around 6 months.

Interleukin-15 Superagonist N-803 in People Experiencing Long COVID (Interrupt-LC)
Upcoming, Not Yet Recruiting
Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms (RECOVER-VITAL)
In Progress, Not Recruiting

RECOVER-VITAL is a 900-person multi-center randomized clinical trial investigating Paxlovid for the treatment of Long COVID. Paxlovid, which is approved for the treatment of acute COVID in the US, works be stopping the virus from replicating. If persistent virus is contributing to Long COVID symptoms, Paxlovid may also help to alleviate symptoms even long after the acute infection. Participation in VITAL lasts around 6 months.