<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447144</url>
  </required_header>
  <id_info>
    <org_study_id>1003</org_study_id>
    <nct_id>NCT04447144</nct_id>
  </id_info>
  <brief_title>Nutritional Habits, and Coronavirus Disease 2019 (COVID-19) Outcome</brief_title>
  <official_title>Nutritional Habits, Does it Affect Coronavirus Disease 2019 (COVID-19) Infection Outcome? An Egyptian Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total&#xD;
      deaths of 913. Post viral entry, intense immune response against the virus with infiltration&#xD;
      of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in&#xD;
      peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability,&#xD;
      thrombosis and multiple organ damage, The gut microbiota and immune homeostasis seem to have&#xD;
      a back and forth relationship.&#xD;
&#xD;
      Also, gut microbiota derived signals are known to tune the immune cells for pro and&#xD;
      anti-inflammatory responses thereby affecting the susceptibility to various diseases. Healthy&#xD;
      gut microbiome essentially could be pivotal in maintaining an optimal immune system to&#xD;
      prevent an array of excessive immune reactions that eventually become detrimental to lungs&#xD;
      and vital organ systems.&#xD;
&#xD;
      Numerous studies have shown that the patient's nutritional status have a significant effect&#xD;
      on an individual's immunity and over all health status and it has been suggested that&#xD;
      nutritional deficiencies may predispose to severe forms of COVID-19 infections.&#xD;
&#xD;
      Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to&#xD;
      delay patients recovery and worsen their prognosis, the reason may be due to aggravated&#xD;
      inflammatory pathology found in NCDs exacerbating COVID-19 infection.&#xD;
&#xD;
      The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients&#xD;
      and whether type of diet (Mediterranean or Western) will affect disease outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total&#xD;
      deaths of 913. There are over six million confirmed cases of COVID-19 and almost 370,000&#xD;
      deaths globally. COVID-19 originated from Wuhan city, China in early 2020, from their&#xD;
      extending to the rest of the world. The virus belong to a large class of viruses known as&#xD;
      β-coronaviruses with a large number of potential natural primary, intermediate and final&#xD;
      hosts. Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is an enveloped RNA&#xD;
      virus that typically spread by droplets causing pulmonary and extra-pulmonary complications.&#xD;
&#xD;
      COVID-19 can result in cytokine storm, which in severe cases can lead to acute respiratory&#xD;
      distress syndrome (ARDS), sepsis and multiple organ dysfunction that can progress to death.&#xD;
      Post SARS-CoV-2 entry, intense immune response against the virus with infiltration of&#xD;
      monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in&#xD;
      peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability,&#xD;
      thrombosis and multiple organ damage. This along with the fact that some patients of this&#xD;
      disease have diarrhea points out towards a distinct possibility of involvement of gut-lung&#xD;
      axis and may be the gut microbiota.&#xD;
&#xD;
      The gut microbiota and immune homeostasis seem to have a back and forth relationship. Also,&#xD;
      gut microbiota derived signals are known to tune the immune cells for pro and&#xD;
      anti-inflammatory responses thereby affecting the susceptibility to various diseases.&#xD;
&#xD;
      Many elderly and immune-compromised patients progress to serious adverse clinical outcomes,&#xD;
      it is therefore tempting to speculate that in COVID-19, there is a possible cross-talk taking&#xD;
      place between the lung and the gut microbiota which might influence the outcome of the&#xD;
      clinical manifestation.&#xD;
&#xD;
      Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system&#xD;
      to prevent an array of excessive immune reactions that eventually become detrimental to lungs&#xD;
      and vital organ systems.&#xD;
&#xD;
      Several studies have shown that increased D-dimer levels are associated with severe forms of&#xD;
      COVID-19 infection, this might be explained by diffuse alveolar damage, pneumocytes&#xD;
      desquamation, pulmonary edema, interstitial mononuclear cells and lymphocytes infiltration&#xD;
      causing intense inflammatory burden induced in severe COVID-19 infections.&#xD;
&#xD;
      Numerous studies have shown that the patient's nutritional status have a significant effect&#xD;
      on an individual's immunity and over all health status and it has been suggested that&#xD;
      nutritional deficiencies may predispose to severe forms of COVID-19 infections. Adequate&#xD;
      Fruits and vegetables consumption have been studied for their potential protective effects&#xD;
      against respiratory diseases and anti-inflammatory effects, furthermore, fruits and&#xD;
      vegetables are also rich sources of fibers that have favorable effects on gut microbiome. One&#xD;
      of very familiar water-soluble vitamins; Vitamin C (ascorbic acid) , that can be found in&#xD;
      citrus fruits, barriers, leafy greens, tomatoes, and various other fruits and vegetables.&#xD;
      Indeed, 1-2 g supplementation of vitamin C was found to shorten the duration of common cold&#xD;
      by 18%, according to the United states National Institute of health (NIH) the recommended&#xD;
      daily allowances (RDA) of vitamin C for healthy adults is 75-90 mg/d.&#xD;
&#xD;
      The Sunshine vitamin (Vitamin D) which is found in mushrooms, eggs, salmon and milk was found&#xD;
      in a meta-analysis of 25 randomized controlled trails conducted over more than 11,000&#xD;
      participants, an overall protective effect of vitamin D supplementation in acute respiratory&#xD;
      infections and, also, COVID-19, studies also suggested to possible role of Vitamin D as an&#xD;
      antiviral immunomodulator through anti-inflammatory properties, for this reason, Vitamin D&#xD;
      have been suggested to have a beneficial effects against SARS-CoV-2 infection (16), another&#xD;
      study done in Switzerland on SARS-CoV-2 positive patients found to have significant lower&#xD;
      levels (mean value 11.1 ng/mL) of 25-hydroxyvitamin D. The recommended RDA of vitamin D&#xD;
      according to NIH 15-20 ug/d (600-800 IU with tolerable upper limit of 4000 IU). Another&#xD;
      vitamin with anti-inflammatory benefits, fat soluble vitamin E (œ-tocopherol) found in seeds,&#xD;
      green leafy vegetables, nuts, and fortified cereals. Vitamin E has been labeled as&#xD;
      immunoenhancing vitamin by with anti-inflammatory properties by regulating the production of&#xD;
      Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS) and modulating signal&#xD;
      transduction, thus protecting The polyunsaturated fatty acids (PUFAs) in the cell membranes,&#xD;
      for this reason, it has been suggested that the combination of Vitamins C, D &amp; E may be&#xD;
      useful in COVID-19 patients. The RDA of Vitamin E for healthy adults according to the NIH is&#xD;
      15 mg/d (tolerable upper level 1000 mg/d).&#xD;
&#xD;
      Regarding minerals, Zinc has been found to have a critical role in maintaining immune cells&#xD;
      integrity and important cofactor for numerous enzyme, zinc deficiency can cause impaired&#xD;
      cell-mediated immunity predisposing to various infections, especially respiratory infections,&#xD;
      available food sources of zinc including; meats, legumes and diary products, the RDA of zinc&#xD;
      according to NIH is 8-11 mg/d (with 40 mg/day tolerable upper intake level).&#xD;
&#xD;
      Another essential trace element is Copper that can be found in nuts and offal and, in lesser&#xD;
      concentrations in cereals and fruits, copper has a pivotal role in maintaining DNA integrity&#xD;
      by its antioxidant effects, studies have shown that adequate copper supplementation can&#xD;
      reduce lung inflammation in mice, according to NIH, the RDA of copper is 900 ug/d (tolerable&#xD;
      upper limit of 10 mg/d).&#xD;
&#xD;
      Regular intake of prebiotic foods such as oligosaccharides, fermentable fibers, and resistant&#xD;
      starches can beneficially affect the gut microbiota, prebiotic fibers are considered&#xD;
      selective substrates for specific beneficial colonic bacteria as they are neither hydrolyzed&#xD;
      nor absorbed in the proximal gut. Dietary fibers have been suggested as immunity modulators&#xD;
      as they lower incidence of bacterial translocation by maintaining integrity of the gut&#xD;
      barrier, available sources include; oat, barley, seeds, nuts, peas and some fruits, the&#xD;
      recommended daily intake is 25-38 g/day. Probiotic foods (from dairy products as yogurt&amp; sour&#xD;
      cream) and supplements have the ability to modify the gut microbiota and potentially modulate&#xD;
      gut inflammatory response.&#xD;
&#xD;
      D-dimer is a fibrin degradation product (FDP) that reflects bath thrombin production and&#xD;
      activation, elevated levels have been linked to increased risk of coronary artery disease,&#xD;
      cerebrovascular strokes and total mortality, so far the link between dietary habits and&#xD;
      D-dimer levels has been poorly explored. Studies have reported, that adherence to a&#xD;
      Mediterranean diet was found to be associated with decreased levels of D-dimer, with possible&#xD;
      antithrombotic effects due to high content of fibers, antioxidants, mono and polyunsaturated&#xD;
      fatty acids.&#xD;
&#xD;
      Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to&#xD;
      delay patients recovery and worsen their prognosis, the reason may be due to aggravated&#xD;
      inflammatory pathology found in NCDs exacerbating COVID-19 infection. Such patients with&#xD;
      underlying cardiovascular, respiratory disease were found to have worse prognosis, diabetes,&#xD;
      hypertension and hypercholesterolemia are considered major risk factors for thrombotic&#xD;
      complications, which in COVID-19 patients may account for higher risk of serious disease&#xD;
      outcome and is associated with two-folds increase in mortality.&#xD;
&#xD;
      Fish and fish oils are considered very beneficial to individual health especially in patients&#xD;
      with NCDs including cardiovascular diseases. Omega-3-polyunsaturated fatty acids (PUFA) are&#xD;
      integral component of the cell membrane thus having anti-inflammatory effects, however,&#xD;
      substantial human trials in this area are lacking.&#xD;
&#xD;
      For this reason, an effective approach to reduce person's risk of developing NCDs is to halt&#xD;
      underlying inflammation via modifiable risk factors including; diet, exercise and healthy&#xD;
      lifestyle choices. To date, there is no single food or natural remedy that has been used for&#xD;
      preventing COVID-19 infections. Healthy diets containing adequate amounts of necessary macro&#xD;
      and micronutrients, prebiotics and probiotics that can maintain and restore immune system,&#xD;
      therefore increasing protection against chronic inflammation-related NCDs. Foods with&#xD;
      anti-inflammatory and immunomodulatory compounds including essential vitamins (C, D &amp; E) and&#xD;
      minerals (Zinc, Copper, Calcium &amp; Selenium) are considered protective foods, these&#xD;
      micronutrients can act in harmony to prevent thrombotic and reactive oxygen species (ROS)&#xD;
      complications by their anti-inflammatory properties. They are present in fair amounts in&#xD;
      Mediterranean Diet, which is characterized by increased dietary consumption of legumes, olive&#xD;
      oil, whole grains, nuts, and monounsaturated fats, minimally processed fruits, vegetables,&#xD;
      associated with low to moderate consumption of fermented dairy products, fish, poultry.&#xD;
      Antithrombotic advantages of Mediterranean diet have been explained by reduced levels of&#xD;
      factor VII, tissue factor, platelets and leucocytes counts in individuals consuming&#xD;
      Mediterranean diet. On the other hand, The &quot;Western&quot; dietary pattern, which is characterized&#xD;
      by high consumption of saturated fats, refined carbohydrates, red meat, deserts and sweets,&#xD;
      that may be associated with hyperglycemia, hyperlipidemia and chronic inflammatory state.&#xD;
&#xD;
      The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients&#xD;
      and whether type of diet (Mediterranean or Western) will affect disease outcomes.&#xD;
&#xD;
      The current study also trying to determine if balanced diet maintaining healthy gut&#xD;
      microbiota can have a role in avoiding disease progression and deterioration in COVID-19&#xD;
      cases.&#xD;
&#xD;
      Dietary pattern questionnaire for COVID 19 patient Name:- Age :- The work:- height :- Weight&#xD;
      :- BMI :-&#xD;
&#xD;
        -  Did you lose weight during the previous 3 months?&#xD;
&#xD;
        -  Do you smoke?&#xD;
&#xD;
        -  What is your usual breakfast before the injury and when to take it ?&#xD;
&#xD;
        -  What is your usual lunch before the injury and when to take it ?&#xD;
&#xD;
        -  What is your usual dinner before the injury and when to take it ?&#xD;
&#xD;
        -  Did you eat between meals and what you eat?&#xD;
&#xD;
        -  How many cups of water you drink daily?&#xD;
&#xD;
        -  Do you eat salads or fresh vegetables daily (type and amount)?&#xD;
&#xD;
        -  Do you eat fruit daily (type and amount )?&#xD;
&#xD;
        -  Do you drink milk daily ?&#xD;
&#xD;
        -  Do you eat yogurt daily?&#xD;
&#xD;
        -  Do you drink fermented milk daily?&#xD;
&#xD;
        -  Do you eat cheese daily(type and amount)?&#xD;
&#xD;
        -  Do you eat fish weekly ( type and amount)?&#xD;
&#xD;
        -  Do you eat pickles daily(amount) ?&#xD;
&#xD;
        -  Are you exposed to the sun daily ( duration and time)?&#xD;
&#xD;
        -  Number of spoons of sugar taken per day ( and sweets)?&#xD;
&#xD;
        -  Types of drinks daily and their times ?&#xD;
&#xD;
        -  Frequency of eating out ( weekly)?&#xD;
&#xD;
        -  Do you eat any of these food daily ( cocoa , cashew , cheddar, chicken , meat, Milk ,&#xD;
           almond , salmon , yogurt)?&#xD;
&#xD;
        -  Number of times eating eggs per week ?&#xD;
&#xD;
        -  The type and amount of fats used in cooking :-&#xD;
&#xD;
        -  Number of hours of sleep per day :-&#xD;
&#xD;
        -  Antibiotic intake rate:-&#xD;
&#xD;
        -  Have you take any supplements and vitamins for the past months?&#xD;
&#xD;
      The analysis of the above food habits questionnaire Will be fitted to a scoring system from 0&#xD;
      to 32 points covering the following&#xD;
&#xD;
        1. Probiotic in food&#xD;
&#xD;
        2. Prebiotic in food&#xD;
&#xD;
        3. Vitamins and minerals in food&#xD;
&#xD;
        4. Mediterranean type of food&#xD;
&#xD;
        5. Antibiotics intake that affect gut microbiota&#xD;
&#xD;
        6. Tea frequency and amount intake with respecting it's role on microbiota&#xD;
&#xD;
        7. Exercise daily and it's effect on immune system and lung capacity&#xD;
&#xD;
      All patients will be followed up for 14 days For disease recovery or progression to severe&#xD;
      category.&#xD;
&#xD;
      Statistical analysis will be done after tabulation of the results to correlate with&#xD;
      microbiome as well as the clinical status of patients.&#xD;
&#xD;
      Aim and Expected outcomes: The novelty of this study is that the investigators will get&#xD;
      information about the role and type of diet on COVID-19 outcome and clarifying the role&#xD;
      certain macro and micronutrients in inducing chronic inflammation, protecting from thrombosis&#xD;
      The investigators also hope through this research to modify dietary habits in the Egyptian&#xD;
      society encouraging healthy nutrition with the pre and probiotics food role to retain normal&#xD;
      healthy life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Western versus Mediterranean diet in COVID-19 outcome</measure>
    <time_frame>2 months</time_frame>
    <description>To assess the relation between type of diet in mild to moderate COVID 19, to the fate of their course; either improvement or progression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gut- Lung axis in COVID-19</measure>
    <time_frame>2 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protective role of minerals and vitamins in COVID-19 patients</measure>
    <time_frame>2 months</time_frame>
    <description>Possible protective effects of minerals and vitamins against COVID-19 respiratory illness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>non-communicable diseases and COVID-19</measure>
    <time_frame>2 months</time_frame>
    <description>Trying to explain the link between non-communicable disease severity and COVID-19 prognosis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Covid19</condition>
  <condition>Chronic Inflammation</condition>
  <condition>Non-Communicable Chronic Diseases</condition>
  <arm_group>
    <arm_group_label>COVID-19 mild severity</arm_group_label>
    <description>Definition of mild cases according to MOH:&#xD;
Age &lt; 60&#xD;
Temperature &lt;38.5&#xD;
arterial oxygen saturation (SaO2) &gt;92%&#xD;
Heart Rate &lt;110&#xD;
Respiratory Rate &lt;25 /min.&#xD;
Neutrophil / lymphocyte ratio on complete blood count (CBC) &lt; 3.1&#xD;
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 &gt; 40)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 moderate severity</arm_group_label>
    <description>Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study is a prospective cross-sectional single center National study, will include 200&#xD;
        Egyptian patients. The patients preliminary suggested to have COVID-19 of mild to moderate&#xD;
        severity that is confirmed by laboratory and imaging studies.&#xD;
&#xD;
        Blood samples will be obtained for:&#xD;
&#xD;
          -  CBC including lymphocyte count and absolute neutrophil count&#xD;
&#xD;
          -  ALT, AST, bilirubin total and direct&#xD;
&#xD;
          -  Serum creatinine, urea&#xD;
&#xD;
          -  C- reactive protein&#xD;
&#xD;
          -  LDH&#xD;
&#xD;
          -  D-dimer&#xD;
&#xD;
          -  Serum ferritin 4. ECG, CXR &amp; CT chest will be done and followed with Labs. 5. A&#xD;
             questionnaire for the diet will be filled by the patient and will be analyzed.&#xD;
&#xD;
             6. All patients will receive Hydroxychloroquine, Vitamin C, Zink tablets,&#xD;
             acetylcysteine and lacorferrin according to The Egyptian Ministry of Health treatment&#xD;
             protocol for COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients (18 -80 years) with mild to moderate COVID-19 cases consented to home or&#xD;
        hospital isolation to follow them.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe cases not fulfilling the definition of mild and moderate cases.&#xD;
&#xD;
        Definition of mild cases according to The Egyptian Ministry Of Health: (MOH)&#xD;
&#xD;
          1. Age &lt; 60&#xD;
&#xD;
          2. Temperature &lt;38.5&#xD;
&#xD;
          3. SaO2 &gt;92%&#xD;
&#xD;
          4. Heart Rate &lt;110&#xD;
&#xD;
          5. Respiratory Rate &lt;25 /min.&#xD;
&#xD;
          6. Neutrophil / lymphocyte ratio on CBC &lt; 3.1&#xD;
&#xD;
          7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled&#xD;
             Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious&#xD;
             heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension),&#xD;
             immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/&#xD;
             organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI &gt; 40) Any patient not&#xD;
             fulfilling the above mild criteria is considered having moderate disease as well as&#xD;
             any positive pulmonary imaging findings&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Abdul Ghani, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lecture of Internal Medicine Hepatology &amp; gastroenterology Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mona M Abd-Elmonem Hegazy, MD</last_name>
    <phone>+20 100 142 1551</phone>
    <email>monahegazy@cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed M Abdul Ghani, MD</last_name>
    <phone>+201005150375</phone>
    <email>abdelgany@staff.cu.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mona A Hegazy, MD</last_name>
      <phone>0201001421551</phone>
      <email>monahegazy@cu.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed M Abdul Ghani, MD</last_name>
      <phone>0201005150375</phone>
      <email>Abdelgany@staff.cu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
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    <citation>John Hopkins University. John Hopkins University &amp; Medicine: Coronavirus Resource Center. Available online: https://coronavirus.jhu.edu/map.html</citation>
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  <reference>
    <citation>Wang L, Wang Y, Ye D, Liu Q. Erratum to ;;A review of the 2019 Novel Coronavirus (COVID-19) based on current evidence'' [International Journal of Antimicrobial Agents 55/6 (2020) 105948]. Int J Antimicrob Agents. 2020 Sep;56(3):106137. doi: 10.1016/j.ijantimicag.2020.106137. Epub 2020 Aug 18. No abstract available.</citation>
    <PMID>32826129</PMID>
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    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
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    <citation>Zhang W, Zhao Y, Zhang F, Wang Q, Li T, Liu Z, Wang J, Qin Y, Zhang X, Yan X, Zeng X, Zhang S. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): The Perspectives of clinical immunologists from China. Clin Immunol. 2020 May;214:108393. doi: 10.1016/j.clim.2020.108393. Epub 2020 Mar 25.</citation>
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    <citation>Chin VK, Yong VC, Chong PP, Amin Nordin S, Basir R, Abdullah M. Mycobiome in the Gut: A Multiperspective Review. Mediators Inflamm. 2020 Apr 4;2020:9560684. doi: 10.1155/2020/9560684. eCollection 2020.</citation>
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    <citation>Negi S, Pahari S, Bashir H, Agrewala JN. Gut Microbiota Regulates Mincle Mediated Activation of Lung Dendritic Cells to Protect Against Mycobacterium tuberculosis. Front Immunol. 2019 May 28;10:1142. doi: 10.3389/fimmu.2019.01142. eCollection 2019.</citation>
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    <citation>Nagpal R, Mainali R, Ahmadi S, Wang S, Singh R, Kavanagh K, Kitzman DW, Kushugulova A, Marotta F, Yadav H. Gut microbiome and aging: Physiological and mechanistic insights. Nutr Healthy Aging. 2018 Jun 15;4(4):267-285. doi: 10.3233/NHA-170030.</citation>
    <PMID>29951588</PMID>
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  <reference>
    <citation>Round JL, Mazmanian SK. Inducible Foxp3+ regulatory T-cell development by a commensal bacterium of the intestinal microbiota. Proc Natl Acad Sci U S A. 2010 Jul 6;107(27):12204-9. doi: 10.1073/pnas.0909122107. Epub 2010 Jun 21.</citation>
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    <citation>Yao Y, Cao J, Wang Q, Shi Q, Liu K, Luo Z, Chen X, Chen S, Yu K, Huang Z, Hu B. D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study. J Intensive Care. 2020 Jul 10;8:49. doi: 10.1186/s40560-020-00466-z. eCollection 2020.</citation>
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    <citation>Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.</citation>
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  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mona Hegazy</investigator_full_name>
    <investigator_title>Professor of Internal Medicine Hepatology &amp; gastroenterology Unit Faculty of medicine, Cairo University, Cairo University</investigator_title>
  </responsible_party>
  <keyword>Covid19</keyword>
  <keyword>noncommunicable diseases</keyword>
  <keyword>chronic inflammation</keyword>
  <keyword>Mediterranean diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Noncommunicable Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 15, 2020</submitted>
    <returned>October 20, 2020</returned>
    <submitted>October 27, 2020</submitted>
    <returned>November 3, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447144
org study id: 1003
nct id: NCT04447144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.

      Several studies have shown that increased D-dimer levels are associated with severe forms of
      COVID-19 infection, this might be explained by diffuse alveolar damage, pneumocytes
      desquamation, pulmonary edema, interstitial mononuclear cells and lymphocytes infiltration
      causing intense inflammatory burden induced in severe COVID-19 infections.

      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. Adequate
      Fruits and vegetables consumption have been studied for their potential protective effects
      against respiratory diseases and anti-inflammatory effects, furthermore, fruits and
      vegetables are also rich sources of fibers that have favorable effects on gut microbiome. One
      of very familiar water-soluble vitamins; Vitamin C (ascorbic acid) , that can be found in
      citrus fruits, barriers, leafy greens, tomatoes, and various other fruits and vegetables.
      Indeed, 1-2 g supplementation of vitamin C was found to shorten the duration of common cold
      by 18%, according to the United states National Institute of health (NIH) the recommended
      daily allowances (RDA) of vitamin C for healthy adults is 75-90 mg/d.

      The Sunshine vitamin (Vitamin D) which is found in mushrooms, eggs, salmon and milk was found
      in a meta-analysis of 25 randomized controlled trails conducted over more than 11,000
      participants, an overall protective effect of vitamin D supplementation in acute respiratory
      infections and, also, COVID-19, studies also suggested to possible role of Vitamin D as an
      antiviral immunomodulator through anti-inflammatory properties, for this reason, Vitamin D
      have been suggested to have a beneficial effects against SARS-CoV-2 infection (16), another
      study done in Switzerland on SARS-CoV-2 positive patients found to have significant lower
      levels (mean value 11.1 ng/mL) of 25-hydroxyvitamin D. The recommended RDA of vitamin D
      according to NIH 15-20 ug/d (600-800 IU with tolerable upper limit of 4000 IU). Another
      vitamin with anti-inflammatory benefits, fat soluble vitamin E (œ-tocopherol) found in seeds,
      green leafy vegetables, nuts, and fortified cereals. Vitamin E has been labeled as
      immunoenhancing vitamin by with anti-inflammatory properties by regulating the production of
      Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS) and modulating signal
      transduction, thus protecting The polyunsaturated fatty acids (PUFAs) in the cell membranes,
      for this reason, it has been suggested that the combination of Vitamins C, D & E may be
      useful in COVID-19 patients. The RDA of Vitamin E for healthy adults according to the NIH is
      15 mg/d (tolerable upper level 1000 mg/d).

      Regarding minerals, Zinc has been found to have a critical role in maintaining immune cells
      integrity and important cofactor for numerous enzyme, zinc deficiency can cause impaired
      cell-mediated immunity predisposing to various infections, especially respiratory infections,
      available food sources of zinc including; meats, legumes and diary products, the RDA of zinc
      according to NIH is 8-11 mg/d (with 40 mg/day tolerable upper intake level).

      Another essential trace element is Copper that can be found in nuts and offal and, in lesser
      concentrations in cereals and fruits, copper has a pivotal role in maintaining DNA integrity
      by its antioxidant effects, studies have shown that adequate copper supplementation can
      reduce lung inflammation in mice, according to NIH, the RDA of copper is 900 ug/d (tolerable
      upper limit of 10 mg/d).

      Regular intake of prebiotic foods such as oligosaccharides, fermentable fibers, and resistant
      starches can beneficially affect the gut microbiota, prebiotic fibers are considered
      selective substrates for specific beneficial colonic bacteria as they are neither hydrolyzed
      nor absorbed in the proximal gut. Dietary fibers have been suggested as immunity modulators
      as they lower incidence of bacterial translocation by maintaining integrity of the gut
      barrier, available sources include; oat, barley, seeds, nuts, peas and some fruits, the
      recommended daily intake is 25-38 g/day. Probiotic foods (from dairy products as yogurt& sour
      cream) and supplements have the ability to modify the gut microbiota and potentially modulate
      gut inflammatory response.

      D-dimer is a fibrin degradation product (FDP) that reflects bath thrombin production and
      activation, elevated levels have been linked to increased risk of coronary artery disease,
      cerebrovascular strokes and total mortality, so far the link between dietary habits and
      D-dimer levels has been poorly explored. Studies have reported, that adherence to a
      Mediterranean diet was found to be associated with decreased levels of D-dimer, with possible
      antithrombotic effects due to high content of fibers, antioxidants, mono and polyunsaturated
      fatty acids.

      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. Such patients with
      underlying cardiovascular, respiratory disease were found to have worse prognosis, diabetes,
      hypertension and hypercholesterolemia are considered major risk factors for thrombotic
      complications, which in COVID-19 patients may account for higher risk of serious disease
      outcome and is associated with two-folds increase in mortality.

      Fish and fish oils are considered very beneficial to individual health especially in patients
      with NCDs including cardiovascular diseases. Omega-3-polyunsaturated fatty acids (PUFA) are
      integral component of the cell membrane thus having anti-inflammatory effects, however,
      substantial human trials in this area are lacking.

      For this reason, an effective approach to reduce person's risk of developing NCDs is to halt
      underlying inflammation via modifiable risk factors including; diet, exercise and healthy
      lifestyle choices. To date, there is no single food or natural remedy that has been used for
      preventing COVID-19 infections. Healthy diets containing adequate amounts of necessary macro
      and micronutrients, prebiotics and probiotics that can maintain and restore immune system,
      therefore increasing protection against chronic inflammation-related NCDs. Foods with
      anti-inflammatory and immunomodulatory compounds including essential vitamins (C, D & E) and
      minerals (Zinc, Copper, Calcium & Selenium) are considered protective foods, these
      micronutrients can act in harmony to prevent thrombotic and reactive oxygen species (ROS)
      complications by their anti-inflammatory properties. They are present in fair amounts in
      Mediterranean Diet, which is characterized by increased dietary consumption of legumes, olive
      oil, whole grains, nuts, and monounsaturated fats, minimally processed fruits, vegetables,
      associated with low to moderate consumption of fermented dairy products, fish, poultry.
      Antithrombotic advantages of Mediterranean diet have been explained by reduced levels of
      factor VII, tissue factor, platelets and leucocytes counts in individuals consuming
      Mediterranean diet. On the other hand, The "Western" dietary pattern, which is characterized
      by high consumption of saturated fats, refined carbohydrates, red meat, deserts and sweets,
      that may be associated with hyperglycemia, hyperlipidemia and chronic inflammatory state.

      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.

      The current study also trying to determine if balanced diet maintaining healthy gut
      microbiota can have a role in avoiding disease progression and deterioration in COVID-19
      cases.

      Dietary pattern questionnaire for COVID 19 patient Name:- Age :- The work:- height :- Weight
      :- BMI :-

        -  Did you lose weight during the previous 3 months?

        -  Do you smoke?

        -  What is your usual breakfast before the injury and when to take it ?

        -  What is your usual lunch before the injury and when to take it ?

        -  What is your usual dinner before the injury and when to take it ?

        -  Did you eat between meals and what you eat?

        -  How many cups of water you drink daily?

        -  Do you eat salads or fresh vegetables daily (type and amount)?

        -  Do you eat fruit daily (type and amount )?

        -  Do you drink milk daily ?

        -  Do you eat yogurt daily?

        -  Do you drink fermented milk daily?

        -  Do you eat cheese daily(type and amount)?

        -  Do you eat fish weekly ( type and amount)?

        -  Do you eat pickles daily(amount) ?

        -  Are you exposed to the sun daily ( duration and time)?

        -  Number of spoons of sugar taken per day ( and sweets)?

        -  Types of drinks daily and their times ?

        -  Frequency of eating out ( weekly)?

        -  Do you eat any of these food daily ( cocoa , cashew , cheddar, chicken , meat, Milk ,
           almond , salmon , yogurt)?

        -  Number of times eating eggs per week ?

        -  The type and amount of fats used in cooking :-

        -  Number of hours of sleep per day :-

        -  Antibiotic intake rate:-

        -  Have you take any supplements and vitamins for the past months?

      The analysis of the above food habits questionnaire Will be fitted to a scoring system from 0
      to 32 points covering the following

        1. Probiotic in food

        2. Prebiotic in food

        3. Vitamins and minerals in food

        4. Mediterranean type of food

        5. Antibiotics intake that affect gut microbiota

        6. Tea frequency and amount intake with respecting it's role on microbiota

        7. Exercise daily and it's effect on immune system and lung capacity

      All patients will be followed up for 14 days For disease recovery or progression to severe
      category.

      Statistical analysis will be done after tabulation of the results to correlate with
      microbiome as well as the clinical status of patients.

      Aim and Expected outcomes: The novelty of this study is that the investigators will get
      information about the role and type of diet on COVID-19 outcome and clarifying the role
      certain macro and micronutrients in inducing chronic inflammation, protecting from thrombosis
      The investigators also hope through this research to modify dietary habits in the Egyptian
      society encouraging healthy nutrition with the pre and probiotics food role to retain normal
      healthy life.
observational model: Cohort
time perspective: Prospective
measure: Western versus Mediterranean diet in COVID-19 outcome
time frame: 2 months
description: To assess the relation between type of diet in mild to moderate COVID 19, to the fate of their course; either improvement or progression
measure: Gut- Lung axis in COVID-19
time frame: 2 months
description: 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
measure: Protective role of minerals and vitamins in COVID-19 patients
time frame: 2 months
description: Possible protective effects of minerals and vitamins against COVID-19 respiratory illness
measure: non-communicable diseases and COVID-19
time frame: 2 months
description: Trying to explain the link between non-communicable disease severity and COVID-19 prognosis
arm group label: COVID-19 mild severity
description: Definition of mild cases according to MOH:
Age < 60
Temperature <38.5
arterial oxygen saturation (SaO2) >92%
Heart Rate <110
Respiratory Rate <25 /min.
Neutrophil / lymphocyte ratio on complete blood count (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)
arm group label: COVID-19 moderate severity
description: Any patient not fulfilling the above mild criteria is considered having moderate disease as well as any positive pulmonary imaging findings
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ahmed M Abdul Ghani, MD
role: Study Director
affiliation: Lecture of Internal Medicine Hepatology & gastroenterology Unit
last name: Mona M Abd-Elmonem Hegazy, MD
phone: +20 100 142 1551
email: monahegazy@cu.edu.eg
last name: Ahmed M Abdul Ghani, MD
phone: +201005150375
email: abdelgany@staff.cu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
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responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mona Hegazy
investigator title: Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University
mesh term: COVID-19
mesh term: Inflammation
mesh term: Chronic Disease
mesh term: Noncommunicable Diseases
submitted: October 15, 2020
returned: October 20, 2020
submitted: October 27, 2020
returned: November 3, 2020