The Study of Brave-LC LDN Treatment Trial
Public ClinicalTrials.gov record NCT07916259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Brave-LC: A Phase 3 Randomized Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of a 16-week Course of Low-dose Naltrexone to Reduce Fatigue Severity in Persons Aged 6 Through 25 Years With Long COVID
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of a 16-week course of low-dose naltrexone (LDN) in approximately 1,300 participants aged 6 to 25 years with fatigue associated with Long COVID. Participants will be enrolled across three age cohorts (6-11, 12-17, and 18-25 years) and randomized 1:1 to receive LDN capsules or matching placebo capsules. LDN will be initiated at 1.5 mg daily and titrated weekly to a maximum tolerated dose of up to 4.5 mg daily. Randomization will be stratified by age cohort, and participants will also be randomized to a pharmacokinetic (PK) sampling window. Primary objective is to compare the change in fatigue severity from baseline to 16 weeks between participants aged 6 to 25 years with Long COVID randomized to a 16-week course of LDN or placebo.
Study identification
- NCT ID
- NCT07916259
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 16, 2026 (Estimated)
- Primary completion
- Dec 31, 2028 (Estimated)
- Completion
- Jan 1, 2029 (Estimated)
- Last update posted
- Nov 4, 2026
2026 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233-0011 | — |
| Exalt Clinical Research Inc. | Chula Vista | California | 91910 | — |
| Denver Health | Denver | Colorado | 80204-4506 | — |
| University of Florida Health | Gainesville | Florida | 32610 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115-6110 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Dartmouth Health | Lebanon | New Hampshire | 03756-1000 | — |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901-1935 | — |
| NYU Langone Hospital - Brooklyn | Brooklyn | New York | 11220 | — |
| Columbia University | New York | New York | 10032 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07916259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2026 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07916259 live on ClinicalTrials.gov.