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Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents

NCT06147050 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-04

No results posted yet for this study

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 neurocognitive impairment (also referred to as 'brain fog'). Based on two systematic reviews of Covid-19 cases in neonates, children and adolescents under 19 years of age, fatigue caused by Long Covid can persist for years and can lead to work disability and labour shortages, posing a public health emergency with lasting health, mental, and economic impacts. To date, no treatment has shown to be broadly effective for the treatment of Long Covid. An experimental study has demonstrated that metformin, a common diabetes drug, might reduce the incidence of long COVID if given during the acute phase of COVID-19. The study, however, did not look at whether metformin would be effective as a treatment for those who already have long COVID. It also did not report the results by age groups, so it is not clear if the effect of metformin differs for people younger than 35 years of age. Therefore, a pilot, adaptive randomized controlled trial, which will evaluate the feasibility of conducting a large platform trial and will also evaluate the efficacy and safety of using metformin (versus placebo, a look-alike substance with no active ingredient) in managing fatigue in long COVID adolescent patients with persistent (long term) features of fatigue (chronic fatigue syndrome) has been proposed.

Conditions

Interventions

DRUG

Metformin

Metformin is an FDA-approved antidiabetic agent that manages high blood sugar levels in type 2 diabetes patients. However, emerging evidence may suggest a benefit to COVID recovery.

OTHER

Placebo

Patients will receive matching placebo control twice daily.

Sponsors & Collaborators

  • Purpose Life Sciences

    lead OTHER

Principal Investigators

  • Zamir Hussain Suhag, MBBS, FCPS · Technical Director of Trust in Vaccines & Immunization, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147050 on ClinicalTrials.gov