National Institute of Allergy and Infectious Diseases (NIAID)
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.
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 rando…
Inclusion Criteria: 1. Aged 6 to 25 years, inclusive, at the time of randomization. 2. Fluent in English and/or Spanish. 3. History of SARS CoV 2 infection shown by (1) a positive nucleic acid amplification test (NAAT) or antigen test, OR (2) meeting clinical criteria\* AND an epidemiologic link\*\* to a confirmed case. \*Clinical criteria is defined as either (1) acute onset of fever AND cough; OR (2) acute altered/loss of taste or smell + one additional symptom including: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, or anorex…
Opioid receptor antagonist used to treat opioid and alcohol use disorders in adults. Formulated as naltrexone hydrochloride, a white, crystalline compound freely soluble in water.
Matching placebo capsule that is visually identical to the active study product and is administered orally once daily according to the same dosing schedule and titration scheme for 16 weeks.