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| Column | Value |
|---|---|
| Trial registration number | NCT05430152 |
|
Full text link
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 11, 2022, 4 a.m. Source : ClinicalTrials.gov |
LDNtrial@phsa.ca |
|
Registration date
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
2022-06-24 |
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Recruitment status
Last imported at : March 2, 2024, 8 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Aug. 8, 2023, 7:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: male and female patients ages 19 to less than 70 years case of sars-cov-2 over 3 previously, confirmed by a positive test result or clinical confirmation by a physician meet the clinical diagnostic criteria for pcfs agree to maintain any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician) agree to use effective contraception for the trial duration, as appropriate, if female. the participant resides within the delivery area for the drug as determined by fedex clinical trial services |
|
Exclusion criteria
Last imported at : Aug. 8, 2023, 7:32 a.m. Source : ClinicalTrials.gov |
pregnant, planning to become pregnant, or breastfeeding opioid medications: any use within last 15 days, as reported by the patient during the trial a positive urine test for opioids (only for the first 16 participants) history of alcohol, opioid or other substance misuse participation in another interventional clinical trial in the last 30 days or planned during the trial period confirmed me/cfs or fm existing prior to sars-cov-2 infection allergy to naltrexone or medication components acute hepatitis, liver failure, or severe kidney failure. current or recent use of naltrexone in the last 30 days the participant is not an ideal candidate for the study, in the opinion of the investigator, for any other reason (ie. personal or logistic, medication, condition, etc.) that could impact the participant's safety or the results of the study. opioid washout period: potential participants who are currently taking opioid medications who wish to enrol the study will be instructed they can stop taking opioid medications for 15 days before continuing the screening process. they will be instructed that they should speak with their family doctor before stopping any prescribed medications. positive urine test for opioids: as regular use of opioid medications is an exclusion criterion, we will do a quality control check with the first 16 participants to test for the presence of opioids in their urine. any participants with a positive test, will be excluded from the study, and such finding will be discussed at the trial steering committee or dsmb for potential trial modification. |
|
Number of arms
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : March 2, 2024, 8 a.m. Source : ClinicalTrials.gov |
Luis Nacul |
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Inclusion age min
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
19 |
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Inclusion age max
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
69 |
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Countries
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Canada |
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Type of patients
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
160 |
|
primary outcome
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Fatigue Intensity |
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Notes
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : June 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "nan", "treatment_id": 855, "treatment_name": "Naltrexone", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}] |