Clinical trial NCT04492228: Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome
Official title: Randomized Open Controlled Clinical Trial to Evaluate the Effectiveness of a Eucaloric Ketogenic Nutrition in Comparison With a Standard Nutrition in Covid-19 Disease in Reducing Cytokine Storm Syndrome and ARDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Ketogenic Dieting
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a controlled, randomized, open-label, clinical trial designed to determine whether a ketogenic diet,in comparison with a standard diet, improves mortality and reduces ventilator requirements or ICU access in patients with coronavirus disease.

The study team will prospectively enroll 50 patients with COVID-19 infection administering a 4:1 ratio ketogenic formula (both enteral or parenteral) and 50 with standard diet
Primary purpose: TREATMENT

Brief summary: Covid 19 pandemia is causing millions of deaths worldwide. To date, the evidence gathered suggests that the subgroup of patients who present the most serious clinical feature of COVID-19 could have a "cytokine storm syndrome" better defined as secondary hemophagocytic lymphohistiocytosis (sHLH), characterized by acute respiratory distress (ARDS) and septic shock, followed by multi-organ failure due to an excess of cytokines induced by the inflammatory response to the virus.

The reduction of phagocytic hyperactivation represents a possible treatment for HLH.

Lowering the availability of glucose, the only substrate of aerobic glycolysis and of the Warburg effect in activated macrophages, through the use of ketogenic diets could be a promising solution.

Actually diet is not recognized as impacting on the evolution of COVID-19, however, scientific literature data show that a low carbohydrate and high lipid diet (ketogenic diet) can inhibit inflammation and lead to a clinical improvement of respiratory function.

The hypothesis of this study is that the administration of a ketogenic diet could improve mortality, lower the access to ICU and the need of NIV.

The plan is to enroll 50 patients with COVID 19 infection and administer a 1:4 ketogenic formula during hospitalization in order to verify these outcomes.


Eligibility criteria: Inclusion Criteria:

* documented clinical diagnosis of COVID-19 supported by clinical features and by the positivity to at least one pharyngeal swab
* age ≥18 years
* informed written consent

Exclusion Criteria:

* Type I diabetes
* Type II diabetes in therapy with insulin, sulphonylureas, repaglinide, GLP-1 analogues, SGLT2 inhibitors
* Recent acute cardiovascular event (within a month)
* Food allergies to diet components
* Any metabolic disorder capable of influencing gluconeogenesis
* Clinical history of severe hypertriglyceridemia with or without pancreatitis
* Pregnancy and/or breastfeeding

Primary outcomes:
measure: Mortality rate in the ketogenic group diet vs standard one
timeFrame: Up to nine months
measure: Access in Intensive Care Unit in the ketogenic group diet vs standard one
timeFrame: Up to nine months
measure: Need of Non Invasive Ventilation in the ketogenic group diet vs standard one
timeFrame: Up to nine months
measure: Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one
timeFrame: Up to nine months
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Samir Giuseppe Sukkar
Study officials:
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