Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-11-24
Brief Title:
Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents
Sponsor:
Purpose Life Sciences
Organization:
Purpose Life Sciences
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVIVE
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 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
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 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 syndromedysautonomia 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 theres no approved therapy for it in managing fatigue in long COVID adolescent patients with persistent features of fatigue chronic fatigue syndrome
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 theres no approved therapy for it in managing fatigue in long COVID adolescent patients with persistent features of fatigue chronic fatigue syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None