Covid19 Clinical Trial
Official title:
Nutritional Habits, Does it Affect Coronavirus Disease 2019 (COVID-19) Infection Outcome? An Egyptian Experience
NCT number | NCT04447144 |
Other study ID # | 1003 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | September 1, 2020 |
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
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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* Note: There are 45 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Protective role of minerals and vitamins in COVID-19 patients | Possible protective effects of minerals and vitamins against COVID-19 respiratory illness | 2 months | |
Primary | non-communicable diseases and COVID-19 | Trying to explain the link between non-communicable disease severity and COVID-19 prognosis | 2 months |
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