COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach
COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach
Living in Canada and being health-worker in the first line face to COVID-19, investigator
 outcome is to teach an experience or explain the disease using a review and get people
 prepared to COVID-19 treatment focused on adherence to the HIV approved 2006-2007 protocol at
 Ghent University but the review shows an older different study approved at the University of
 Kinshasa and its ethics approval that again is an old document. So no ethics document
 supporting the study exists as it is now and no registration. It is an observational study
 and therefore would not usually require registration in order for the results to be
 published. It is not a type of secondary literature. The formula TOMEKA® (Mix porridge of
 maize, sorghum, and soya) follows FOOD + HEALTH CLAIM. It is scientifically justified,
 relevantly used, and correctly communicated. Methodology: sufficient data? scientific
 consensus? correct methodology? correct population? context: significant results? context of
 use, realistic ingestion? correct target group? communication: consumer perception?
 exaggerated/insinuative, clear, precise, complete, correct information? not misleading?
 correctly presented? The product TOMEKA® tried to fulfill to above questions in a fitting way
 with COVID-19 which is an emerging, rapidly evolving situation without a vaccine.
On 12/06/2020 worldwide, COVID-19 affected 7 273 958 confirmed cases with 413 372 deaths, 97
 894 confirmed in Canada with 8 048 deaths, 53 666 confirmed cases in Quebec with 5 148
 deaths, 4 637 confirmed cases with 101 deaths in the Democratic Republic of the Congo where
 the situation is disastrous: an immense country and the ways of communication are difficult
 and damaged. It becomes gymnastics to get a drug package.

 The principal investigator provide the details of this study to be available to the public in
 getting knowledge of Covid-19 and micronutrients using the product TOMEKA®.

 The individual contribution of ingredients in the nutritional composition of TOMEKA® (mixed
 flour). Composition of TOMEKA® (Clinical Research Protocol): 100 g of TOMEKA contain 20.1 g
 of protein; 57.8 g of carbohydrates, 10.1 g of lipids; 8.5 mg iron; 117.6 mg Calcium; 16.6 mg
 Sodium; 55 μg of Selenium and 378.6 kcal of energy.TOMEKA will be made with soy, maize,
 sorghum. The above calculations were made with the food composition table (no laboratory
 analyzes).

 Quantity to be served per meal (in g): 30 g for 6-8 months (113,4 Kcal of Energy per served
 meal). 40 g for 9-11 months (151 Kcal): 50 g for 12-23 months and more expecting to provide
 189 Kcal of energy per served per meal. Each group needs 4-5 meals a day to get the
 equivalent of their daily nutritional needs.

 The study will focus on Selenium, a powerful non-enzymatic antioxidant, more powerful than
 Vit C and Vit E combined. The formula TOMEKA® follows FOOD + HEALTH CLAIM.

 A clear device to follow micronutrients and Covid-19 symptoms:

 Example 1: Vitamin D and Covid-19 (Press release from the National Academy of Medicine in
 France May 22, 2020) Vitamin D is a prohormone synthesized in the dermis under the effect of
 ultraviolet rays, that is to say of the rays of the sun, then transported in the liver and
 the kidney where it is transformed into an active hormone. It is responsible for the
 intestinal absorption of calcium and bone health, but vitamin D also has unconventional
 effects. In particular, it modulates the functioning of the immune system by stimulating
 macrophages and dendritic cells [1,2,3]. It plays a role in regulating and suppressing the
 cytokine inflammatory response which causes acute respiratory distress syndrome which
 characterizes the severe and often lethal forms of Covid-19. A significant correlation
 between low serum vitamin D levels and mortality by Covid-19 has been shown [4]. This
 phenomenon generally follows a North-South gradient, although there are exceptions such as
 the Nordic countries where the supplementation of the nutrients in vitamin D, in particular
 milk products, is systematic. On the other hand, the countries of southern Europe
 surprisingly display a high prevalence of vitamin D deficiency despite higher sunshine [5].
 This would explain why children who receive vitamin D regularly have asymptomatic forms of
 Covid-19 and fewer complications. Vitamin D cannot be considered as a preventive or curative
 treatment for SARS-CoV-2 infection; but by mitigating the inflammatory storm and its
 consequences, it could be considered as an adjunct to any form of therapy.

 The National Academy of Medicine in France recalls that the administration of vitamin D
 orally is a simple, inexpensive measure and reimbursed by Health Insurance; - confirms its
 recommendation to ensure vitamin D supplementation in the French population in a report in
 2012 [2]; - recommend that the serum vitamin D level (i.e. 25OHD) be measured quickly in
 people over 60 years of age with Covid-19 and that it be administered in the event of a
 deficiency, a loading dose of 50,000 to 100,000 IU which could help limit respiratory
 complications; - recommends providing vitamin D supplementation of 800 to 1,000 IU / day in
 people under the age of 60 as soon as the diagnosis of Covid-19 is confirmed.

 Example 2: Selenium and Covid-19

 Now is the time to give extra attention to a balanced diet and assure an optimum dietary
 micronutrient and vitamin intake! Particularly the micronutrient selenium plays an essential
 role in antioxidant functioning and helps to alleviate the negative health impacts of viral
 infections, including inflammation of the lungs (see e.g. https://lnkd.in/eqAGhDH).

 Particularly elderly people are often selenium-deficient, which was proven to be the case in
 e.g. Italy (see https://lnkd.in/epFKVEY). However, when taking micronutrient and vitamin
 supplements, also follow the instructions to avoid over-supplementation! A healthy and
 balanced diet is the safest way towards an appropriate dietary micronutrient and vitamin
 intake.

 Description of what investigators will measure:

 1. The Production of Medical Knowledge:

 2. Learning medicine:

 How it will be measured:

 1. The Production of Medical Knowledge: Anthropology/Medicine. It is substantial and it
 showed by the title.

 2. Learning medicine: The clinical trial shows that medical anthropology connects
 anthropology and social theory generally with some of the more significant questions of
 our epoch with the COVID-19 pandemic.

 And at what time points it will be measured:

 1. The Production of Medical Knowledge: the principal investigator has received
 notifications from Researchgate about 700 researchers who read his research theme, so it
 deserves to be widely read and taught.

 2. Learning medicine: This is an original trial, which combines theoretical argument with
 empirical observation

 Objectives:

 1. Investigators would like the participant to accept the notion that all knowledge is
 socially and culturally constructed.

 2. Investigators would examine the contexts in which that knowledge is produced talking on
 the theme of nutrition in research and aiming to act in medicine, psychiatry,
 epidemiology, and anthropology.

 3. Investigators would like the participant acts in behavioral medicine, public health,
 epidemiology, anthropology as well as .nutrition.

 The hypothesis of investigators work:

 1. Patients with COVID-19 have an increased demand for Selenium

 2. Selenium supplementation reduces the viral rate

 3. Selenium supplementation improves the BMI of COVID-19 patients

 4. Selenium supplementation reduces COVID-19 related morbidity

 5. Selenium supplementation postponed COVID-19 related mortality

 6. Selenium supplementation is adjuncted to any form of COVID-19 therapy with nutrition
 education

 7. Nutrition education improves health status

 8. Selenium supplementation and nutrition education should be incorporated into the global
 Nutritional care and support of COVID-19 patients

 Methodology: observational study using a questionnaire.

 Study Population:

 Age: 15-75

 Sex: M, F

 Inclusion Criteria:

 Fulfill Inclusion criteria and accept:

 The participant is asked on the symptoms of the COVID-19 with a questionnaire. If he/she
 can write yes to any of these questions in order to be tested:

 In the past 4 hours, have you taken any medicines for fever or headaches, such as
 acetaminophen (Paracetamol, Tylenol, Tempra), ibuprofen (Advil, Motrin) or Aspirin?

 Yes

 No

 Do you have a thermometer to take your body temperature?

 Yes

 No

 If you don't have a thermometer, do you have any of the following symptoms: warm
 forehead, muscle or joint pain, chills, general weakness?

 Yes

 No

 In the past 24 hours, have you had trouble breathing or been short of breath?

 Yes

 No

 In the past 24 hours, have you had chest pain?

 Yes

 No

 Do you have a cough? Or if you have a health condition that is causing you to cough, is
 your cough worse than usual?

 Yes

 No

 In the past 24 hours, have you had a sore throat?

 Yes

 No

 In the past 24 hours, have you had a runny nose?

 Yes

 No

 In the past 24 hours, have you felt a loss of smell (in the absence of nasal
 congestion)?

 Yes

 No

 In the past 24 hours, have you had diarrhea (three or more bowel movements)?

 Yes

 No

 In the past 24 hours, have you had a headache?

 Yes

 No

 In the past 24 hours, have you felt more tired than usual and unable to carry out your
 daily activities?

 Yes

 No

 COVID-19 patients confirmed

 be regular on appointments

 Exclusion Criteria:

 COVID-19 suspected clinically

 Children

 refuse to participate

 Initial assessment for the exclusion of suspected Covid-19 cases:

 - New or exacerbated cough: Yes/No

 - Sore throat: Yes/No

 - Fever: Yes/No

 - Intestinal gastritis symptoms (Diarrhea, nausea or vomiting): Yes/No

 - Anosmia (loss of smell) / Ageusia (loss of taste): Yes/No

 -  Shortness of breath: Yes/No

 -  Sputum production: Yes/No

 -  Weakness: Yes/No

 -  Headache: Yes/No

 -  Myalgia / athralgia: Yes/No

 -  Nasal congestion: Yes/No

 -  Hemoptysis: Yes/No

 -  Conjunctivitis: Yes/No

 Comments:

 If yes to any of these questions: rule out an acute health condition. If no acute cause
 identified, consider the person as a probable case and transfer to the warm unit.

 2. Atypical geriatric signs

 -  Sudden loss of autonomy (less than 1 week)

 -  Sudden change in mental state (over 1 week)

 -  Sudden change in behavior (new behavior or cessation of behavior (less than 1 week)

 -  Geriatric fever (Oral or rectal temperature greater than or equal to 37.8 C or if
 increase of 1.1 C compared to the usual normal T)

 Other comments:

 …………………………………………………………………………………………………………..
 .............................................................................................
 .............................................................................................
 .............................................................................................
 .............................................................................................
 ....................................................................

 3. Physical examination inspection:

 -  Assessment of mental state

 -  Attention span: attentive, not attentive

 -  State of consciousness: hyper-alert (or agitation), Lethargic (verbal), alert stupor
 (physical, comatose

 4. Basic settings:

 Vital signs:

 Pulse: ……… / min TA: .......... / ……………. T: ................ C (fever if bu oral or rectal
 sup or equal 37.8 C or if 1.1 C increase compared to the usual normal T)

 Breathing:

 Frequency: ......... / min

 Type: Abdominal chest

 Amplitude: normal deep surface

 Rhythm: regular irregular

 Draw: yes no

 Saturation (normal to 94% and +, unless otherwise indicated):

 Saturation: ............% ambient AIr With O2 …… ..L / min

 5. Auscultation:

 Anterior side

 Abnormal noise: Yes No

 Name if possible:

 Sibilant

 Ronchis

 Right bronchus (A)

 Left bronchus (B)

 Posterior side

 Presence of abnormal noise:

 Yes

 No

 Name if possible:

 Sibilant

 Crackling

 Lower right row

 Left lower lobe

 6. Medical decision making

 Prescribed screening test (oro-nasopharyngeal sample): yes no

 If the sample confirms the presence of COVID-19, isolate the patient in the warm unit.

 7. Clinical monitoring of COVID-19 confirmed or suspected

 Stable patient

 Respiratory rate : q 2h and as needed

 SpO2 and Temperature: per day and as needed

 Blood pressure and Cardiac frequency: per day

 Unstable patient (having had an episode of respiratory distress)

 Respiratory rate: every hour and as needed

 SpO2 and Temperature: per day and as needed

 Surname and first name of doctor

 Permits

 Signature

 DD / MM / YYYY

 HH: MM

 References:

 1. - Liu PT, Stenger S, et al. Toll like receptor triggering of a vitamin D mediated
 humanantimicrobial response. Science, 2006, 311 : 1770.

 2. - Rapport de l'Académie nationale de médecine. Statut vitaminique, rôle extra osseux
 etbesoins quotidiens en vitamine D. Bull Acad Natle Med. 2012, 196, 1011.

 3. - Laird E, Rhodes JM and Kenny RA. Vitamin D and inflammation : potential implications
 for severity of Covid-19. Irish med J, 2020, 113 : 81.

 4. - McCartney DM, Byrne DG. Optimisation of vitamin D status impact mortality fromSARS
 -CoV-2 infection Irish Med J .2020 113 : 58.5- Lips P, Cashman KD, et al. Current
 vitamin D status in European and Middle East countries and strategies to prevent vitamin
 D deficiency : a position statement of the European Calcified Tissue Society. Eur J
 Endocrinol, 2019, 180 : P23-P54.

 Links:

 https://lnkd.in/eqAGhDH https://lnkd.in/epFKVEY
Inclusion Criteria:

 -  Fulfill Inclusion criteria and accept

 -  COVID-19 patients confirmed

 -  be regular on appointments

 Exclusion Criteria:

 -  COVID-19 suspected clinically

 -  Children

 -  refuse to participate