Abstract
Background: Dengue is a disease of major global importance. While most symptomatic infections are mild, a small proportion of patients progress to severe disease with risk of hypovolaemic shock, organ dysfunction and death. In the absence of effective antiviral or disease modifying drugs, clinical management is solely reliant on supportive measures. Obesity is a growing problem among young people in Vietnam and is increasingly recognised as an important risk factor for severe dengue, likely due to alterations in host immune and inflammatory pathways. Metformin, a widely used anti-hyperglycaemic agent with excellent safety profile, has demonstrated potential as a dengue therapeutic in vitro and in a retrospective observational study of adult dengue patients with type 2 diabetes. This study aims to assess the safety and tolerability of metformin treatment in overweight and obese dengue patients, and investigate its effects on several clinical, immunological and virological markers of disease severity. Methods: This open label trial of 120 obese/overweight dengue patients will be performed in two phases, with a metformin dose escalation if no safety concerns arise in phase one. The primary endpoint is identification of clinical and laboratory adverse events. Sixty overweight and obese dengue patients aged 10-30 years will be enrolled at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. Participants will complete a 5-day course of metformin therapy and be compared to a non-treated group of 60 age-matched overweight and obese dengue patients. Discussion: Previously observed antiviral and immunomodulatory effects of metformin make it a promising dengue therapeutic candidate in appropriately selected patients. This study will assess the safety and tolerability of adjunctive metformin in the management of overweight and obese young dengue patients, as well as its effects on markers of viral replication, endothelial dysfunction and host immune responses. Trial registration: ClinicalTrials.gov: NCT04377451 (May 6 th 2020).
Highlights
Dengue is a disease of major global importance
This study aims to assess the effect of metformin, a drug known to attenuate inflammatory processes in the context of obesity, on the disease course of dengue in overweight and obese children and young adults
The cohort of patients enrolled in this study will form the active treatment group, while the control group will consist of overweight and obese dengue patients that participated in a matched cohort observational study, none of whom received metformin therapy
Summary
Dengue is a major threat to global public health, with an estimated annual incidence of 390 million infections worldwide, leading to approximately 96 million symptomatic cases and 22,000 deaths in more than 120 countries[1]. If the five-day safety and clinical data of cohort 1 show no safety concerns, the study will progress to the second phase (cohort 2) This will include 25 adults and 25 children, who will be given a weightbased dose of metformin; 1000mg (500mg twice daily) for participants with weight
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