NE3107 in Adults With Neurological Symptoms of Long COVID (NCT06847191) | Clinical Trial Compass
Active — Not RecruitingPhase 2
NE3107 in Adults With Neurological Symptoms of Long COVID
United States203 participantsStarted 2025-04-29
Plain-language summary
Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue.
Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID.
Participants will:
* Take NE3107 or a placebo twice daily for 84 days
* Visit the clinic 5 times for checkups and tests and have a follow up phone call
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult participants ≥18 to \<70 years of age at Screening
. Long COVID with neurological symptoms as defined below:
. Current symptoms of at least fatigue and neurocognitive impairment that began or worsened after an index SARS-CoV-2 infection that occurred at least 3 months prior to screening. Index SARS-CoV-2 infection is defined as either: 1) an episode of COVID-19 with a positive nucleic acid or antigen test during acute illness, as documented in the medical record, or 2) a documented clinical diagnosis of COVID-19, which can be based on a patient-reported positive test for COVID-19. Note that a documented diagnosis of Long COVID is not required for inclusion.
. Symptoms cannot be explained by any concomitant condition or diagnosis, in the opinion of the investigator.
. Symptom duration for at least 3 months.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial for Long COVID neurological symptoms — what does that phase mean in terms of how much we already know about whether NE3107 is safe and actually helps with cognitive problems?
2The trial is actively enrolling but no longer recruiting new participants — is there any chance I could still get involved, or are there similar studies I should be looking into instead?
3Since the main thing they're measuring is performance on a cognitive battery called Cogstate, does that align with the specific memory or thinking problems I'm experiencing, and is that kind of improvement something that would matter for my daily life?
4How does trying this experimental treatment compare to any standard-of-care options currently available for the neurological symptoms of Long COVID — is there a reason to pursue one path before the other?
5Given that this trial is specifically focused on neurological symptoms of Long COVID, would my doctor consider my particular symptom profile a good fit for what this study is designed to test?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in performance on the Cogstate Cognition battery*
. PROMIS Fatigue SF13a T score ≥ 50 (≥ normative mean) after rounding to nearest integer.
. If taking medications for glycemic control at the time of Screening, must be stable on the current dosage and form for ≥ 3 months prior to randomization and expected to remain stable throughout participation in the study.
. Willing and able to provide voluntary written informed consent, complete the surveys, clinical assessments, and participate in the virtual follow-up visit at the end of the 4-week follow-up period (the End of Study visit).
. Agree to maintain any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician)
. Females taking hormone replacement therapy (HRT) must have maintained a stable regimen for at least 6 months prior to randomization and agree to continue the regimen until completing the final safety assessment in Week 16.
. Must meet one of the following criteria:
. Females: Must be postmenopausal (postmenopausal status must be confirmed as no menstrual bleeding for \>1 year, or via a follicle stimulating hormone \[FSH\] assessment at Screening), or have been surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) at least 6 months prior to Screening or agree to highly effective contraception, such as double barrier methods (e.g. condom with spermicide, IUD with spermicide). Oral contraceptives alone are insufficient.
. Males: If not vasectomized, must be abstinent or agree to use a double barrier contraception method and indicate that their partner is using highly effective birth control (as defined in 11a) until the end of the study.