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ketocovidiet: Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome

Sponsor
Ospedale Policlinico San Martino (Other)
Overall Status
Recruiting
CT.gov ID
NCT04492228
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ketogenic diet
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 dietThis 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
May 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketogenic diet group

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

Other: Ketogenic diet
Eucaloric Ketogenic diet % composition : protein (27%), lipids (67%), carbohydrates (6%: <30g/day). In pts in artificial nutrition : Eucaloric Ketogenic parenteral nutrition % composition : aminoacids (27%), lipids (67%), carbohydrates (6%: <30g/day)
No Intervention: Standard diet group

patients with COVID-19 feeding with a standard diet

Outcome Measures

Primary Outcome Measures

  1. Mortality rate in the ketogenic group diet vs standard one [Up to nine months]

  2. Access in Intensive Care Unit in the ketogenic group diet vs standard one [Up to nine months]

  3. Need of Non Invasive Ventilation in the ketogenic group diet vs standard one [Up to nine months]

  4. Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one [Up to nine months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samir Giuseppe Sukkar Genova Italy 16132

Sponsors and Collaborators

  • Ospedale Policlinico San Martino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sukkar Samir, MD, Dr Samir Giuseppe Sukkar, Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier:
NCT04492228
Other Study ID Numbers:
  • KETOCOV-1
First Posted:
Jul 30, 2020
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Cytokine Release Syndrome

Study Results

No Results Posted as of Sep 30, 2020