Trial · NCT06147050
Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents
NCT06147050, Phase 3, Unknown, Purpose Life Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents. Trials, record NCT06147050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06147050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents
- NCT number
- NCT06147050
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 16 participants, estimated
- Lead sponsor
- Purpose Life Sciences
- Conditions
- Long COVID
- Interventions
- Metformin, Placebo
- First posted
- 2023-11-27
- Last updated
- 2024-03-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS) score at 90 days post-randomization | 90 days post-randomization | The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain |
| Secondary | Mean PedsQL-MFS score at 30 days post-randomization | 30 days post-randomization | The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain |
| Secondary | Mean PedsQL-MFS score at 60 days post-randomization | 60 days post-randomization | The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain |
| Secondary | Mean Chalder Fatigue Scale (CFS) score at 30 days post-randomization | 30 days post-randomization | The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations |
| Secondary | Mean CFS score at 60 days post-randomization | 60 days post-randomization | The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations |
| Secondary | Mean CFS score at 90 days post-randomization | 90 days post-randomization | The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations |
| Secondary | Mean difference in change in health-related quality of life (HRQL) measured by EQ-5D-Y over 90 days from randomization | 90 days post-randomization | The EQ-5D questionnaires used globally as a generic measure of health status. The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The younger patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. The EQ VAS records the younger patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". |
| Secondary | Odds ratio of the all-cause death over 90 days from randomization. | 30, 60 and 90 days post-randomization | Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints |
| Secondary | Odds ratio of all-cause unexpected hospitalization over 90 days | 30, 60 and 90 days post-randomization | Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints |
| Secondary | Safety of metformin in this patient population | 90 days post-randomization | Incidence of Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) from the day of first visit till end of study visit (90 days post randomization) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06147050
GET https://conductscience.org/api/trials/v1/NCT06147050/registered