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Clinical Trials/NCT04447144
NCT04447144UnknownNot Applicable

Nutritional Habits, Does it Affect Coronavirus Disease 2019 (COVID-19) Infection Outcome? An Egyptian Experience

Cairo University1 site in 1 country200 target enrollmentStarted: June 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Western versus Mediterranean diet in COVID-19 outcome

Study Overview

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

Detailed Description

As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. There are over six million confirmed cases of COVID-19 and almost 370,000 deaths globally. COVID-19 originated from Wuhan city, China in early 2020, from their extending to the rest of the world. The virus belong to a large class of viruses known as β-coronaviruses with a large number of potential natural primary, intermediate and final hosts. Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is an enveloped RNA virus that typically spread by droplets causing pulmonary and extra-pulmonary complications.

COVID-19 can result in cytokine storm, which in severe cases can lead to acute respiratory distress syndrome (ARDS), sepsis and multiple organ dysfunction that can progress to death. Post SARS-CoV-2 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. This along with the fact that some patients of this disease have diarrhea points out towards a distinct possibility of involvement of gut-lung axis and may be the gut microbiota.

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.

Many elderly and immune-compromised patients progress to serious adverse clinical outcomes, it is therefore tempting to speculate that in COVID-19, there is a possible cross-talk taking place between the lung and the gut microbiota which might influence the outcome of the clinical manifestation.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)
  • •Temperature <38.5
  • •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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mona Hegazy

Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University

Cairo University

Study Sites (1)

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