Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents

Launched by PURPOSE LIFE SCIENCES · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether metformin, a medication commonly used to treat diabetes, can help reduce fatigue in adolescents who are experiencing long COVID. Long COVID can cause lasting symptoms like extreme tiredness and difficulties with thinking clearly, which can affect young people's daily lives and future opportunities. The trial aims to see if giving metformin to teenagers aged 10 to 18 who have had COVID-19 and are struggling with ongoing fatigue for at least three months can help improve their symptoms compared to a placebo, which is a substance with no active ingredients.

To be eligible for this trial, participants must be between 10 and 18 years old, have had a confirmed case of COVID-19, and report significant fatigue that has lasted for at least 90 days. They should not be currently hospitalized or have other serious health issues that would make participation unsafe. If they join the study, they will be monitored closely and asked to fill out questionnaires about their symptoms. This trial is not open for recruitment yet, but it hopes to provide valuable information on how to help young people dealing with long COVID.

Gender

ALL

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