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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492228
Recruitment Status : Unknown
Verified September 2020 by Sukkar Samir, MD, Ospedale Policlinico San Martino.
Recruitment status was:  Recruiting
First Posted : July 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Sukkar Samir, MD, Ospedale Policlinico San Martino

Study Description
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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
Covid19 Ketogenic Dieting Other: Ketogenic diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : September 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mortality rate in the ketogenic group diet vs standard one [ Time Frame: Up to nine months ]
  2. Access in Intensive Care Unit in the ketogenic group diet vs standard one [ Time Frame: Up to nine months ]
  3. Need of Non Invasive Ventilation in the ketogenic group diet vs standard one [ Time Frame: Up to nine months ]
  4. Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one [ Time Frame: Up to nine months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492228


Contacts
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Contact: Samir G Sukkar, MD 0105553985 samir.sukkar@hsanmartino.it

Locations
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Italy
Samir Giuseppe Sukkar Recruiting
Genova, Italy, 16132
Contact: Samir G Sukkar, MD    00393356098178    samir.sukkar@hsanmartino.it   
Contact: Livia Pisciotta, MD    00393471055508    livia.pisciotta@unige.it   
Sponsors and Collaborators
Ospedale Policlinico San Martino
More Information
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Publications:

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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: July 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Cytokine Release Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock