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

NCT04447144 | Unknown

• 1 other identifier: 1003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; Chronic Inflammation; Non-Communicable Chronic Diseases

Keywords

Covid19; noncommunicable diseases; chronic inflammation; Mediterranean diet

Outcome Measures

Primary Outcomes (4)

• Western versus Mediterranean diet in COVID-19 outcome

  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 months

• Gut- Lung axis in COVID-19

  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

  2 months

• Protective role of minerals and vitamins in COVID-19 patients

  Possible protective effects of minerals and vitamins against COVID-19 respiratory illness

  2 months

• non-communicable diseases and COVID-19

  Trying to explain the link between non-communicable disease severity and COVID-19 prognosis

  2 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Egypt

RECRUITING

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MeSH Terms

Conditions

COVID-19; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed M Abdul Ghani, MD

  Lecture of Internal Medicine Hepatology & gastroenterology Unit

  STUDY DIRECTOR

Central Study Contacts

Mona M Abd-Elmonem Hegazy, MD

CONTACT

+20 100 142 1551; monahegazy@cu.edu.eg

Ahmed M Abdul Ghani, MD

CONTACT

+201005150375; abdelgany@staff.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

EG (1)