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NCT06366724 · ClinicalTrials.gov registry record · Phase 2

LIFT: Life Improvement Trial

A Phase 2 study of Long COVID and ME/CFS, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
Phase 2
Development phase
160
Enrollment target
1
Study location

NCT06366724 is a Phase 2 study of Long COVID and ME/CFS that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 160 participants, below the 2,185-participant average among 50 other Long COVID trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06366724, a Phase 2 study of Long COVID and ME/CFS, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
Phase 2
Development phase
160 participants
Enrollment target
1
Study location

Study Summary

The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI. This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily. The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial. The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete. The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.

Conditions Studied

Long COVID ME/CFS PASC

Interventions

  • OTHER Placebo
  • DRUG Pyridostigmine
  • DRUG Low-Dose Naltrexone

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2024-09-10
Est. Completion 2026-11
Phase Phase 2

Sponsor

Brigham and Women's Hospital

937 total trials

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What the Registry Record Tells You About NCT06366724

The ClinicalTrials.gov registry entry for NCT06366724 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,185-participant average among 50 other Long COVID trials with a reported enrollment target (93% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Long COVID appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06366724 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06366724 about?

NCT06366724 is a clinical study titled "LIFT: Life Improvement Trial". The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (M...

What is the current status of trial NCT06366724?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2024-09-10. Estimated completion is 2026-11.

What conditions does trial NCT06366724 study?

This clinical trial studies the following conditions: Long COVID, ME/CFS, PASC.

What interventions are being tested in trial NCT06366724?

The interventions under investigation include: Placebo (OTHER), Pyridostigmine (DRUG), Low-Dose Naltrexone (DRUG).

Who is sponsoring clinical trial NCT06366724?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06366724 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.