COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach

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:

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