Purpose Life Sciences
Jamir Hussain Suhag
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.
Long COVID
Metformin
Placebo
PHASE3
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 long after the acute phase of infection and could not be explained by other factors. The patient community who first recognized and reported this new syndrome used the term 'long COVID' to describe the post-acute and chronic sequelae of SARS-CoV-2 infection. Long COVID (sometimes referred to as 'post-acute sequelae of COVID-19') is a multisystem condition comprising often severe symptoms that follow a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This condition affects all individuals ubiquitously regardless of their race, age, gender, baseline health status and the severity of their initial COVID infection. As reported by the two systematic reviews of the total COVID-19 cases of neonates, children, and adolescents aged less than 19 years since the start of the pandemic, the persistent clinical features spectrum of long COVID is wide with fatigue having the second highest percentage of persistent long COVID symptoms within this age group. Long COVID symptoms can last for years, particularly in cases for chronic fatigue syndrome/dysautonomia which can be lifelong. Therefore, significant proportions of individuals have been unable to return to work which has even to led to labour shortages. Consequently, long COVID is considered a public health emergency that can have lasting health, mental health, and economic sequelae. Since, the clinical trials done so far have not been prioritized to understand the diagnosis, treatment, and prevention in marginalized populations such as adolescents and because of the high disability associated with this condition, research targeting this age group for the management of long COVID is needed. There are currently no approved therapies for long COVID; however, treatments for certain components have been effective for subsets of populations. Metformin has been proposed in this study as a potential avenue for the management of chronic fatigue that is associated with long COVID. It has clinical benefits when used as an outpatient treatment for COVID-19 and is globally available, has a low-cost, and is safe. A study that was conducted recently had reported that its use in patients infected with COVID could reduce the incidence of long COVID. However, since this study had only focused on older individuals who were already infected with COVID, a pilot trial evaluating the efficacy and safety of metformin in younger individuals with long COVID is warranted. Therefore, a pilot, adaptive randomized controlled trial has been proposed, which will evaluate the feasibility of conducting a large platform trial and will also evaluate the efficacy and safety of using metformin versus placebo, (since there's no approved therapy for it) in managing fatigue in long COVID adolescent patients with persistent features of fatigue (chronic fatigue syndrome).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 16 participants |
| Masking : | TRIPLE |
| Primary Purpose : | TREATMENT |
| Official Title : | Pilot Study of an Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Metformin in Reducing Fatigue in Long COVID Adolescent Patients With Chronic Fatigue Syndrome |
| Actual Study Start Date : | 2024-04 |
| Estimated Primary Completion Date : | 2024-10 |
| Estimated Study Completion Date : | 2024-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 10 Years to 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Karachi, Sindh, Pakistan, 75510