Nutritional Habits, and Coronavirus Disease 2019 (COVID-19) Outcome
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ClinicalTrials.gov Identifier: NCT04447144 |
Recruitment Status : Unknown
Verified June 2020 by Mona Hegazy, Cairo University.
Recruitment status was: Recruiting
First Posted : June 25, 2020
Last Update Posted : June 30, 2020
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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 |
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Covid19 Chronic Inflammation Non-Communicable Chronic Diseases |

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 |
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COVID-19 mild severity
Definition of mild cases according to MOH:
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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
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- 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
- 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
- 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
- non-communicable diseases and COVID-19 [ Time Frame: 2 months ]Trying to explain the link between non-communicable disease severity and COVID-19 prognosis

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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 |
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
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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
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)
- Age < 60
- Temperature <38.5
- SaO2 >92%
- Heart Rate <110
- Respiratory Rate <25 /min.
- Neutrophil / lymphocyte ratio on CBC < 3.1
- 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

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
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 |
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 |
Study Director: | Ahmed M Abdul Ghani, MD | Lecture of Internal Medicine Hepatology & gastroenterology Unit |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Covid19 noncommunicable diseases chronic inflammation Mediterranean diet |
COVID-19 Inflammation Chronic Disease Noncommunicable Diseases Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pathologic Processes Disease Attributes |