Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT06147050
Eligibility Criteria:
Inclusion Criteria:
* Age 10 to 18 years at time of screening
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved)
* Previous confirmed case of SARS-CoV-2 infection (e.g., communicates that they previously had a positive nucleic acid amplification test or had a positive professional use or self-test SARS-CoV-2 rapid antigen diagnostic test)
* New or worsening symptoms since acute COVID-19 illness that have persisted for a duration of at least 90 days but less than 365 days
* Not currently hospitalized or requiring hospitalization
* Patients with childbearing potential or with partners of childbearing potential must agree to use adequate methods of contraception during the trial and through 90 days of follow-up
* Able to complete the questionnaires
* Reports moderate to severe fatigue, defined as a score of 75 or lower on the PedsQL-MFS
* Fatigue symptoms have been present for at least 90 days since time of COVID-19 infection
* Fatigue symptoms are not attributable to another cause (in opinion of investigator)
* Willingness to follow the trial procedures
Exclusion Criteria:
* Known active acute SARS-CoV-2 infection
* Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not related to SARS-CoV-2 infection
* Known pre-existing dysautonomia, not related to SARS-CoV-2 infection
* Diabetes
* Known stroke within 3 months of screening
* Known severe anemia, defined as \< 8 g/dL21
* Known diagnosis of Lyme disease
* Any non-marijuana illicit drug use within 30 days prior to informed consent
* Pregnancy or breastfeeding
* Current co-morbid psychiatric disorder (e.g. clinical depression, anxiety, sleep disorder, eating disorder, substance abuse) that is uncontrolled and associated with significant symptoms or that requires a prohibited medication
* Taking medications with known side effect of chronic fatigue
* Contraindications to metformin
* Patients with a history of seizures may participate if they have not occurred in the last 60 days and are stable, under pharmacological control
* Any condition that would make the patient, in the opinion of the investigator, unsuitable for the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT06147050
Study Brief:
Protocol Section:
NCT06147050