Covid19TomekaNCT04537585
COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7
A study testing Tomeka® and "Vernonia amygdalina" in people with Covid19, run by Guyguy K Tshima, MD at 1 site in Democratic Republic of the Congo.
Trial summary
Investigators study meet the World Health Organization definition of a clinical trial because it is a prospective study in which participants will be assigned to intervention groups to investigate the effects on health outcomes. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Tomeka® and "Vernonia amygdalina"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Nov 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients eligible for the trial must comply with all of the following at randomization:
- Age ≥15 years
- Current admission under the care of the heart-failure service at the site
- Fulfill Inclusion criteria and accept
- COVID-19 patients confirmed
- be regular on appointments
Show all 11Show fewer
- No voluntary patient (see: having signed the informed consent) The criteria for choosing subjects: subjects who are themselves exposed to the consumption of Vernonia amygdalina (Kananga, Tshikapa or in Kasaï region). This group can be part of the cohort. tare: to compare with a no exposure group which is external to the cohort.
- Here is the follow-up procedure for the two groups throughout the study:
- follow-up modality: visits, letters, work-study
- frequency of contacts: monthly
- total duration of follow-up: 9 months Patients enrolled in the individual data investigational study are potential candidates for TOMEKA intervention. As the TOMEKA protocol does not involve any investigational agents or techniques, patients would be eligible for dual randomization if they are themselves on stable doses of Vernonia amygdalina (the investigational herbs drugs may equivalent to Remdesivir).
Who cannot join
- COVID-19 suspected clinically
- Children
- Refuse to participate
- Recover when possible the cause of a study exit:
- refusal of follow-up
- move
- death If the patient is no longer followed in the study without any cause being identified, then he is lost to follow-up.
Trial locations and contacts
1 site in 1 country.
Guyguy K. Tshima, MD contact
Democratic Republic of the Congo1 site
Cliniques Universitaires de Kinshasa
Kinshasa, BP KIN XI
About this study
Official title: A Multi-center, Investigator-blinded, Randomized Clinical Trial, 18-months, Parallel-group to Compare the Efficacy of Tomeka® Foods Versus Vernonia Amygdalina in the Prevention and Maintenance of Remission of COVID-19 in DRC
Investigators study meet the World Health Organization definition of a clinical trial because it is a prospective study in which participants will be assigned to intervention groups to investigate the effects on health outcomes. Investigators highlighted clearly the real problem that indigeneous patients are facing now in the Democratic Republic of the Congo: Poverty meaning the lack of money to buy goods and drugs. From the news report, investigators learned that "In the Democratic Republic of the Congo, indigenous communities in Kananga, Tshikapa and in the Kasai region are increasing their consumption of "Vernonia amygdalina," a traditional plant believed to cure several diseases, including alleviating COVID-19." Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their antiviral mechanisms. Furthermore, the antiviral capabilities of these molecules are significantly stronger than or at least equivalent to Remdesivir. The target zones of these molecules in the human body cover a set of important organs and tissues. For example, Vernolide (C19H22O7) is able to reside firmly at bronchi, the upper respiratory tract, and blood vessels.
From the news report, investigators learned also that Herbs used in Tanzania include lemon, ginger, neem tree leaves, mango tree leaves, orange tree leaves. These traditional medicines contain, more or less, antiviral molecules whose capacities range from good to outstanding levels. Those herbs have been used worldwide to fight COVID-19.
Read more
In conclusion traditional medicines have been playing important roles not only in Africa but also in Asia, in South America, etc. Herbs prove themselves with effective efficacies in many therapeutic practices.
So maybe after careful considerations, the World Health Organization may support the use of herbs for poor patients who cannot afford modern drugs and used traditional medicines after a positive COVID-19 test in the Democratic Republic of the Congo. Investigators are talking about a randomisation's nuance process to follow participants who decide by themselves if diagnosed positive to COVID-19 to begin to take herbs not waiting for a physician prescription.
Read the detailed description
Background Selenium supplementation is suggested for an intervention better in food intake. The Tomeka Prevention Trial (TPT) is a randomized double blind nutri prevention trial. Initial blood collection will be specifically for the analysis of Selenium [antioxidant] and storage of serum. An additional blood collection will be carried out using anticoagulants so that plasma and white blood cells can be isolated. Plasma will allow the analysis of additional biomarkers collecting measurements of renin-angiotensin-system markers such as Angiotensin-2 and Angiotensin 1-7. This serum will be used (among other possible uses) for studies to investigate the antioxidant effect of Vernonia amygdalina in organs which may influence COVID-19 risk in emergency situations.
The TOMEKA WBC [white blood cell] sample will be available to TOMEKA investigators as well as outside researchers who have important, timely hypotheses to test. Because the sample bank is a limited resource, proposals to use it will be evaluated in terms of scientific relevance, significance, and validity as well as the potential impact of the proposed study. The amount and type of material needed will also be considered and the efficient use of material will be required. Strict confidentiality will be exercised and the information provided to investigators will not contain personal identifiers.
When specific uses of the TOMEKA WBC samples will be approved, the protocol will be amended.
Objectives To provide a resource for studies of early markers, etiology, and genetic risk factors for COVID-19. To collect measurements of renin-angiotensin-system markers, such as angiotensin-2 and angiotensin 1-7.
Methods Because the original model consent form did not specifically address herbal studies, participants will be asked to sign an additional consent form to document their consent to the collection and submission of additional blood samples for storage and future testing (including laboratory analysis). WHO? Everyone aged 15 and up experiencing symptoms of fever, cough, or shortness of breath with confirmed active COVID-19. WHY? To see if the investigational use of Tomeka® will prevent hospitalization and death, in COVID-19 patients. WHAT? The study type is observational after using patient individual data and investigators are assigned prospectively to monitor symptoms of the COVID-19 with a questionnaire. At the slightest symptom associated with the COVID-19 virus present in the patient's individual data, namely: fever (38 degrees c or 100, 4 degrees F), new or exacerbated cough, shortness of breath, sore throat, loss of smell, sudden onset without nasal congestion or loss of taste, digestive symptoms (nausea, vomiting / diarrhea), general weakness, headache, myalgia. Participants from the patient individual database will be randomized (like flipping a coin) to one of two groups. The intervention is education that needs to be evaluated with the suggested Tomeka® foods (nutraceuticals).
Conclusion The protocol presents a treatment model developed in its early stages with individual medical files. The principal investigator had the idea to create a treatment build or based on the principle of antioxidant supplementation, proteins, lipids, energy intake. The protocol is leading to a serious need of nutraceuticals solution faced to the missing cheap COVID-19 vaccine problem when it will be available. The nutritional status of each COVID-19-infected patient should be assessed prior to undertaking treatments. The outcome objective is to teach. The total budget required for the project is from 250.000 US$ to 1.000.000 US$ for education based on individual patient data and implementation on a global scale. This theoretical study merits further investigation for possible inclusion of nutraceuticals as an alternative for fighting and eradicating COVID-19.
- Conditions
- Covid19
- Being tested
- Tomeka®, "Vernonia amygdalina"
- Keywords
- Covid 19, Tomeka®, Vernonia amygdalina, Selenium, DRC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomeka®Combination product
Also called Maze, Soy, Sorghum, Mushrooms
Tomeka® is a farine mixte made by soy, sorghum, maze and mushrooms
"Vernonia amygdalina"Drug
Also called Congo Bololo (D. R. Congo), grawa (Amharic), ewuro (Yoruba), etidot (Efik)
"Vernonia amygdalina" is the Intervention that was pre-specified to be administered as part of the protocol as a particular intervention of not "of interest" because the World Health Organization doesn't support its use due to two reports case of toxicity in Kinshasa in a child and Mbandaka in an adult in the Democratic Republic of the Congo that why investigators would like review its usage in a large community and update that intervention of not "of interest" as appropriate (using randomisation on the follow up of participants who will take by themselves those herbs called Congo Bololo to compare, as necessary, to the ones who are afraid to take them because of reported cases of toxicity).
| Study group | Role | What they receive |
|---|---|---|
| Tomeka | Experimental | Number of participants with treatment-TOMEKA® usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour Receives: Combination Product: Tomeka®; Drug: "Vernonia amygdalina" |
| "Vernonia amygdalina" | Experimental | Number of participants with "Vernonia amygdalina" herbs usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour Receives: Combination Product: Tomeka®; Drug: "Vernonia amygdalina" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-TOMEKA® usage
process assessed by Education
Measured: 18 months
Secondary outcomes (1)
Change From Baseline in herbs Vernonia amygdalina usage
take care of the Covid-19
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators couldn't agree more to wait without to know how to treat their patients better and want to learn about therapeutic nutrition approach called TOMEKA versus prophylaxis dosing of antioxidant as Vernonia amygdalina as a study. Investigators are learning about that here in September, why wasn't that done in April? Investigators would submit to follow a parallel group, just speaking as researchers about randomisation, one of the reasons difficult to reach that elaborate study design is sometimes bureaucracy is just daunting.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guyguy K Tshima, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Médical de Kinshasa (CMK)
- Responsible party
- Sponsor-investigator, Guyguy K Tshima, MD, University of Kinshasa
- Investigators
- Guyguy K. Tshima, MD, Principal investigator, University of Kinshasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537585
- Sponsor's protocol ID
- TOMEKA
- Acronym
- Tomeka
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The main thing investigators touched upon was funding, and they guess they would say that other researchers will frankly admit that they think just in terms of Food and herbs there are no funds for clinical trials. It will be through free websites that investigators plan to share their research. Mainly investigators plan to use Researchgate to share their results, also through peer-review journals and books.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Investigator-blinded, Randomized Clinical Trial, 18-months, Parallel-group to Compare the Efficacy of Tomeka® Foods Versus Vernonia Amygdalina in the Prevention and Maintenance of Remission of COVID-19 in DRC
- ClinicalTrials.gov ID
- NCT04537585
- Acronym / sponsor ID
- Tomeka / TOMEKA
- Conditions
- Covid19
- Keywords
- Covid 19, Tomeka®, Vernonia amygdalina, Selenium, DRC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Guyguy K Tshima, MDUniversity, hospital or other
- Collaborators
- Centre Médical de Kinshasa (CMK)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators study meet the World Health Organization definition of a clinical trial because it is a prospective study in which participants will be assigned to intervention groups to investigate the effects on health outcomes. Investigators highlighted clearly the real problem that indigeneous patients are facing now in the Democratic Republic of the Congo: Poverty meaning the lack of money to buy goods and drugs. From the news report, investigators learned that "In the Democratic Republic of the Congo, indigenous communities in Kananga, Tshikapa and in the Kasai region are increasing their consumption of "Vernonia amygdalina," a traditional plant believed to cure several diseases, including alleviating COVID-19." Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their antiviral mechanisms. Furthermore, the antiviral capabilities of these molecules are significantly stronger than or at least equivalent to Remdesivir. The target zones of these molecules in the human body cover a set of important organs and tissues. For example, Vernolide (C19H22O7) is able to reside firmly at bronchi, the upper respiratory tract, and blood vessels.
From the news report, investigators learned also that Herbs used in Tanzania include lemon, ginger, neem tree leaves, mango tree leaves, orange tree leaves. These traditional medicines contain, more or less, antiviral molecules whose capacities range from good to outstanding levels. Those herbs have been used worldwide to fight COVID-19.
In conclusion traditional medicines have been playing important roles not only in Africa but also in Asia, in South America, etc. Herbs prove themselves with effective efficacies in many therapeutic practices.
So maybe after careful considerations, the World Health Organization may support the use of herbs for poor patients who cannot afford modern drugs and used traditional medicines after a positive COVID-19 test in the Democratic Republic of the Congo. Investigators are talking about a randomisation's nuance process to follow participants who decide by themselves if diagnosed positive to COVID-19 to begin to take herbs not waiting for a physician prescription.
Detailed description
Background Selenium supplementation is suggested for an intervention better in food intake. The Tomeka Prevention Trial (TPT) is a randomized double blind nutri prevention trial. Initial blood collection will be specifically for the analysis of Selenium [antioxidant] and storage of serum. An additional blood collection will be carried out using anticoagulants so that plasma and white blood cells can be isolated. Plasma will allow the analysis of additional biomarkers collecting measurements of renin-angiotensin-system markers such as Angiotensin-2 and Angiotensin 1-7. This serum will be used (among other possible uses) for studies to investigate the antioxidant effect of Vernonia amygdalina in organs which may influence COVID-19 risk in emergency situations.
The TOMEKA WBC [white blood cell] sample will be available to TOMEKA investigators as well as outside researchers who have important, timely hypotheses to test. Because the sample bank is a limited resource, proposals to use it will be evaluated in terms of scientific relevance, significance, and validity as well as the potential impact of the proposed study. The amount and type of material needed will also be considered and the efficient use of material will be required. Strict confidentiality will be exercised and the information provided to investigators will not contain personal identifiers.
When specific uses of the TOMEKA WBC samples will be approved, the protocol will be amended.
Objectives To provide a resource for studies of early markers, etiology, and genetic risk factors for COVID-19. To collect measurements of renin-angiotensin-system markers, such as angiotensin-2 and angiotensin 1-7.
Methods Because the original model consent form did not specifically address herbal studies, participants will be asked to sign an additional consent form to document their consent to the collection and submission of additional blood samples for storage and future testing (including laboratory analysis). WHO? Everyone aged 15 and up experiencing symptoms of fever, cough, or shortness of breath with confirmed active COVID-19. WHY? To see if the investigational use of Tomeka® will prevent hospitalization and death, in COVID-19 patients. WHAT? The study type is observational after using patient individual data and investigators are assigned prospectively to monitor symptoms of the COVID-19 with a questionnaire. At the slightest symptom associated with the COVID-19 virus present in the patient's individual data, namely: fever (38 degrees c or 100, 4 degrees F), new or exacerbated cough, shortness of breath, sore throat, loss of smell, sudden onset without nasal congestion or loss of taste, digestive symptoms (nausea, vomiting / diarrhea), general weakness, headache, myalgia. Participants from the patient individual database will be randomized (like flipping a coin) to one of two groups. The intervention is education that needs to be evaluated with the suggested Tomeka® foods (nutraceuticals).
Conclusion The protocol presents a treatment model developed in its early stages with individual medical files. The principal investigator had the idea to create a treatment build or based on the principle of antioxidant supplementation, proteins, lipids, energy intake. The protocol is leading to a serious need of nutraceuticals solution faced to the missing cheap COVID-19 vaccine problem when it will be available. The nutritional status of each COVID-19-infected patient should be assessed prior to undertaking treatments. The outcome objective is to teach. The total budget required for the project is from 250.000 US$ to 1.000.000 US$ for education based on individual patient data and implementation on a global scale. This theoretical study merits further investigation for possible inclusion of nutraceuticals as an alternative for fighting and eradicating COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators couldn't agree more to wait without to know how to treat their patients better and want to learn about therapeutic nutrition approach called TOMEKA versus prophylaxis dosing of antioxidant as Vernonia amygdalina as a study. Investigators are learning about that here in September, why wasn't that done in April? Investigators would submit to follow a parallel group, just speaking as researchers about randomisation, one of the reasons difficult to reach that elaborate study design is sometimes bureaucracy is just daunting.
| Arm | Type | Receives |
|---|---|---|
| Tomeka | Experimental | Combination Product: Tomeka®, Drug: "Vernonia amygdalina"Number of participants with treatment-TOMEKA® usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour |
| "Vernonia amygdalina" | Experimental | Combination Product: Tomeka®, Drug: "Vernonia amygdalina"Number of participants with "Vernonia amygdalina" herbs usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥15 years
- Current admission under the care of the heart-failure service at the site
- Fulfill Inclusion criteria and accept
- COVID-19 patients confirmed
- be regular on appointments
Key exclusion criteria (7 listed)
- COVID-19 suspected clinically
- Children
- Refuse to participate
- Recover when possible the cause of a study exit:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomeka®Also: Maze, Soy, Sorghum, MushroomsTomeka® is a farine mixte made by soy, sorghum, maze and mushrooms | Combination product | "Vernonia amygdalina", Tomeka |
| "Vernonia amygdalina"Also: Congo Bololo (D. R. Congo), grawa (Amharic), ewuro (Yoruba), etidot (Efik)"Vernonia amygdalina" is the Intervention that was pre-specified to be administered as part of the protocol as a particular intervention of not "of interest" because the World Health Organization doesn't support its use due to two reports case of toxicity in Kinshasa in a child and Mbandaka in an adult in the Democratic Republic of the Congo that why investigators would like review its usage in a large community and update that intervention of not "of interest" as appropriate (using randomisation on the follow up of participants who will take by themselves those herbs called Congo Bololo to compare, as necessary, to the ones who are afraid to take them because of reported cases of toxicity). | Drug | "Vernonia amygdalina", Tomeka |
Primary outcome
Number of participants with treatment-TOMEKA® usage
Time frame: 18 months
process assessed by Education
1 secondary outcome
Change From Baseline in herbs Vernonia amygdalina usage
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Yes. The main thing investigators touched upon was funding, and they guess they would say that other researchers will frankly admit that they think just in terms of Food and herbs there are no funds for clinical trials. It will be through free websites that investigators plan to share their research. Mainly investigators plan to use Researchgate to share their results, also through peer-review journals and books.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guyguy K. Tshima, MD contact
Guyguy K. Tshima, MD principal investigator
University of Kinshasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomeka® and "Vernonia amygdalina" in people with Covid19, run by Guyguy K Tshima, MD at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guyguy K. Tshima, MD (0015143819264, guyguytshimakabundi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-TOMEKA® usage (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.