Status:
NOT_YET_RECRUITING
Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents
Lead Sponsor:
Purpose Life Sciences
Conditions:
Long COVID
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief Summary
Long Covid is a multisystem condition comprising often severe symptoms that follow a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Long COVID often manifests as fatigue and n...
Detailed Description
Shortly after the beginning of the COVID-19 global pandemic, reports emerged showing that some individuals infected with SARS-CoV-2 developed persistent symptoms and new health problems that arose lon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06147050
Start Date
April 1 2024
End Date
December 1 2024
Last Update
March 4 2024
Active Locations (1)
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1
Suite No 301, Al-Sehat Centre, Adj Regent Plaza Hotel Rafiqui Shaheed Road
Karachi, Sindh, Pakistan, 75510