Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome (ketocovidiet)

Ospedale Policlinico San Martino

Status: Unknown

Conditions: Ketogenic Dieting; Covid19

Treatments: Other: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04492228

KETOCOV-1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ketogenic diet group

Experimental group

Description:

patients with COVID-19 feeding with a ketogenic diet (4.1 formula)

Treatment:

Other: Ketogenic diet

Standard diet group

No Intervention group

Description:

patients with COVID-19 feeding with a standard diet