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Low-Dose Naltrexone for Post-COVID Syndrome

Not yet recruiting at 12 trial locations
RC
Overseen ByRECOVER Central Contact
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

LM

Laura Malone, MD PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for children, teens, and young adults aged 6 to 25 who have ongoing fatigue due to Long COVID. Participants must be able to take capsules by mouth and follow the study procedures.

Inclusion Criteria

Participants of childbearing potential must agree to use highly effective contraception or true abstinence throughout study
Participant scores below 70 on Pediatric Quality of Life Multidimensional Fatigue Scale at Visit 01A
Willing and able to provide informed consent and assent before study procedures
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Exclusion Criteria

I have a new medical condition causing ongoing fatigue, not due to Long COVID.
Clinically significant mental health condition including prior suicide attempt, hospitalization for mental health in past 6 months, moderate/high risk on C-SSRS, or severe conduct disorder posing safety risk or interfering with trial endpoints
Plans to become pregnant or father a child during trial or pregnant/breastfeeding at randomization
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Dose Naltrexone (LDN)

Trial Overview

The study tests whether low-dose naltrexone (LDN) helps reduce fatigue in people with Long COVID compared to a placebo. Participants are randomly assigned to get either LDN or a look-alike inactive pill for 16 weeks without knowing which one they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-Dose NaltrexoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

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