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Nutritional Habits, and Coronavirus Disease 2019 (COVID-19) Outcome

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447144
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mona Hegazy, Cairo University

Brief Summary:

As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. Post viral entry, intense immune response against the virus with infiltration of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability, thrombosis and multiple organ damage, The gut microbiota and immune homeostasis seem to have a back and forth relationship.

Also, gut microbiota derived signals are known to tune the immune cells for pro and anti-inflammatory responses thereby affecting the susceptibility to various diseases. Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system to prevent an array of excessive immune reactions that eventually become detrimental to lungs and vital organ systems.

Numerous studies have shown that the patient's nutritional status have a significant effect on an individual's immunity and over all health status and it has been suggested that nutritional deficiencies may predispose to severe forms of COVID-19 infections.

Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to delay patients recovery and worsen their prognosis, the reason may be due to aggravated inflammatory pathology found in NCDs exacerbating COVID-19 infection.

The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients and whether type of diet (Mediterranean or Western) will affect disease outcomes


Condition or disease
Covid19 Chronic Inflammation Non-Communicable Chronic Diseases

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Habits, Does it Affect Coronavirus Disease 2019 (COVID-19) Infection Outcome? An Egyptian Experience
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Group/Cohort
COVID-19 mild severity

Definition of mild cases according to MOH:

  1. Age < 60
  2. Temperature <38.5
  3. arterial oxygen saturation (SaO2) >92%
  4. Heart Rate <110
  5. Respiratory Rate <25 /min.
  6. Neutrophil / lymphocyte ratio on complete blood count (CBC) < 3.1
  7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI > 40)
COVID-19 moderate severity
Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings



Primary Outcome Measures :
  1. Western versus Mediterranean diet in COVID-19 outcome [ Time Frame: 2 months ]
    To assess the relation between type of diet in mild to moderate COVID 19, to the fate of their course; either improvement or progression

  2. Gut- Lung axis in COVID-19 [ Time Frame: 2 months ]
    To asses any possible links between gut microbiome and the lung affecting clinical presentation of mild to moderate COVID cases; as diarrhea, loss of taste or smell

  3. Protective role of minerals and vitamins in COVID-19 patients [ Time Frame: 2 months ]
    Possible protective effects of minerals and vitamins against COVID-19 respiratory illness

  4. non-communicable diseases and COVID-19 [ Time Frame: 2 months ]
    Trying to explain the link between non-communicable disease severity and COVID-19 prognosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is a prospective cross-sectional single center National study, will include 200 Egyptian patients. The patients preliminary suggested to have COVID-19 of mild to moderate severity that is confirmed by laboratory and imaging studies.

Blood samples will be obtained for:

  • CBC including lymphocyte count and absolute neutrophil count
  • ALT, AST, bilirubin total and direct
  • Serum creatinine, urea
  • C- reactive protein
  • LDH
  • D-dimer
  • Serum ferritin 4. ECG, CXR & CT chest will be done and followed with Labs. 5. A questionnaire for the diet will be filled by the patient and will be analyzed.

    6. All patients will receive Hydroxychloroquine, Vitamin C, Zink tablets, acetylcysteine and lacorferrin according to The Egyptian Ministry of Health treatment protocol for COVID-19

Criteria

Inclusion Criteria:

- Patients (18 -80 years) with mild to moderate COVID-19 cases consented to home or hospital isolation to follow them.

Exclusion Criteria:

Severe cases not fulfilling the definition of mild and moderate cases.

Definition of mild cases according to The Egyptian Ministry Of Health: (MOH)

  1. Age < 60
  2. Temperature <38.5
  3. SaO2 >92%
  4. Heart Rate <110
  5. Respiratory Rate <25 /min.
  6. Neutrophil / lymphocyte ratio on CBC < 3.1
  7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI > 40) Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings

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): NCT04447144


Contacts
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Contact: Mona M Abd-Elmonem Hegazy, MD +20 100 142 1551 monahegazy@cu.edu.eg
Contact: Ahmed M Abdul Ghani, MD +201005150375 abdelgany@staff.cu.edu.eg

Locations
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Egypt
Faculty of Medicine Cairo University Recruiting
Cairo, Egypt
Contact: Mona A Hegazy, MD    0201001421551    monahegazy@cu.edu.eg   
Contact: Ahmed M Abdul Ghani, MD    0201005150375    Abdelgany@staff.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed M Abdul Ghani, MD Lecture of Internal Medicine Hepatology & gastroenterology Unit
Publications:
John Hopkins University. John Hopkins University & Medicine: Coronavirus Resource Center. Available online: https://coronavirus.jhu.edu/map.html
Wang, L.-S.; Wang, Y.-R.; Ye, D.-W.; Liu, Q.-Q. A review of the 2019 novel coronavirus (COVID-19) based on current evidence. Int. J. Antimicrob. Agents 2020, in press
Krinsky,N.I.; Beecher,G. ; Burk,R.; Chan,A.; Erdman,j.J.; Jacob,R.; Jialal,I.; Kolonel,L.; Marshall,J.;Taylor Mayne, P.R. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids; A Report of the Panel on Dietary Antioxidants and Related Compounds, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Institute of Medicine; The National Academies Press: Washington, DC, USA, 2000.
De lValle, H.B. ; Yaktine, A.L .;Taylor,C.L. ;Ross, A.C.Dietary Reference Intakes for Calcium and \vitaminD. In Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; National Academies Press: Cambridge, MA, USA, 2011.
19. Wu,D.; Meydani, S.N. Vitamin E ,immunity, and infection. In Nutrition, Immunity, and Infection; CRC Press: Boca Raton, FL, USA, 2017; pp. 197-212.
Arrieta,M.C.; Meddings,J.; Field,C.J. The immunomodulatory effects of dietary fiber and prebiotics in the gastrointestinal tract. In Non digestible Carbohydrates and Digestive Health; Paeschke, T.M., Aimutis, W.R., Eds.; Blackwell Publishing Ltd. and Institute of Food Technologists: Ames, IA, USA, 2011; pp. 37-77.

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Responsible Party: Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04447144    
Other Study ID Numbers: 1003
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Hegazy, Cairo University:
Covid19
noncommunicable diseases
chronic inflammation
Mediterranean diet
Additional relevant MeSH terms:
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Inflammation
Chronic Disease
Noncommunicable Diseases
Pathologic Processes
Disease Attributes