ow Dose Naltrexone for the treatment of long COVID-19

Phase 1

Recruiting

Conditions: long COVID
Post COVID-19 Condition
Post-acute sequelae of COVID-19
Infection - Other infectious diseases
Respiratory - Other respiratory disorders / diseases
Inflammatory and Immune System - Other inflammatory or immune system disorders

Registration Number: ACTRN12623001042639

Lead Sponsor: Griffith University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

Participants with long COVID according to the World Health Organization working case definition (Individuals with a history of probable or confirmed SARS-CoV-2 (COVID-19) three months from COVID-19 onset with symptoms lasting at least two months).

Present with symptoms including cognitive disturbances (brain fog), sleep disturbances, and/or body pain.

Exclusion Criteria

i.Current respiratory infections
ii.Intercurrent SARS-CoV-2 reinfection during trial period (this will be considered drop-out)
iii.Previous clinical diagnosis of ME/CFS
iv.Chronic pain history prior to long COVID onset
v.Adverse reaction to LDN or compounded constituents
vi.Chronic opioid or substitution therapy
vii.Daily opioid use in three months prior to, or during trial
viii.Substance abuse, dependence, addiction
ix.History of drug, alcohol abuse and recreational drugs
x.Pregnancy or breastfeeding
xi.Renal dysfunction (eGFR greater than 30 ml/min/1.73m2), liver dysfunction (ALT or AST greater than 300 IU/L).
xii.Active cancer.
xiii.Inflammatory (rheumatological, GIT, dermatological) or neurological condition (demyelinating).
xiv.Neuroimmune modulators: DMARDs, steroids, minocycline, metformin.
xv.History of anxiety, depression and/or other psychiatric concerns.
xvi.Language, cognition, no computer literacy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DSQ Symptom Inventory Questionnaire<br>Determine detectable change in symptom presentation and severity. [ Baseline, six weeks (mid-trial), and 12 weeks (primary endpoint) after intervention commencement. ]

Secondary Outcome Measures

Name	Time	Method
36 item short form health survey<br>Changes in quality of life[ Baseline, 6 weeks (mid-trial) and 12 weeks post intervention commencement. ];Fibromyalgia Impact Questionnaire Revised (FIQR)<br>Assess body pain and impact on health. [ Baseline, 6 weeks (mid-trial) and 12 weeks post intervention commencement. ];Checklist Individual Strength (CIS)<br>Determine changes in the impact fatigue, concentration, motivation and activity has on health.[ Baseline, 6 weeks (mid-trial) and 12 weeks post intervention commencement. ];Clinical Global Impression<br>Track any changes in symptoms.[ Measured fortnightly from baseline until week 12 (endpoint). ]