Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7 (Tomeka)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537585
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Centre Médical de Kinshasa (CMK)
Information provided by (Responsible Party):
Guyguy K Tshima, MD, University of Kinshasa

Tracking Information
First Submitted Date  ICMJE August 29, 2020
First Posted Date  ICMJE September 3, 2020
Last Update Posted Date September 3, 2020
Estimated Study Start Date  ICMJE November 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
Number of participants with treatment-TOMEKA® usage [ Time Frame: 18 months ]
process assessed by Education
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
Change From Baseline in herbs Vernonia amygdalina usage [ Time Frame: 18 months ]
take care of the Covid-19
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7
Official Title  ICMJE 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
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description:
The fact that you can't really study anything unless there's funding for it because the insurance companies and the hospitals are not going to pay for things on a trial unless there is funding. Then you add to that there is no funding for food as medicine, and things as herbs like Vernonia amygdalina that improve the quality of life in COVID-19 patients and they are not pharmaceutical. Those are sort of the real-world complaints, investigators would say, on the front lines to follow participants in parallel group i.e. compare the ones who take herbs as medicine for their survival and other who use others means to fight COVID-19 symptoms.
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Combination Product: Tomeka®
    Tomeka® is a farine mixte made by soy, sorghum, maze and mushrooms
    Other Names:
    • Maze
    • Soy
    • Sorghum
    • Mushrooms
  • Drug: "Vernonia amygdalina"
    "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).
    Other Names:
    • Congo Bololo (D. R. Congo)
    • grawa (Amharic)
    • ewuro (Yoruba)
    • etidot (Efik)
    • onugbu (Igbo)
    • ityuna (Tiv),
    • oriwo (Edo)
    • Awɔnwono (Akan)
    • chusar-doki (Hausa),
Study Arms  ICMJE
  • Experimental: Tomeka
    Number of participants with treatment-TOMEKA® usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour
    Interventions:
    • Combination Product: Tomeka®
    • Drug: "Vernonia amygdalina"
  • Experimental: "Vernonia amygdalina"
    Number of participants with "Vernonia amygdalina" herbs usage as assessed by Education [ Time Frame: 18 months ] Change people's behaviour
    Interventions:
    • Combination Product: Tomeka®
    • Drug: "Vernonia amygdalina"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2020)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

  1. Age ≥15 years
  2. Current admission under the care of the heart-failure service at the site
  3. Fulfill Inclusion criteria and accept
  4. COVID-19 patients confirmed
  5. be regular on appointments
  6. 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).

Exclusion Criteria:

  1. COVID-19 suspected clinically
  2. Children
  3. Refuse to participate
  4. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guyguy K. Tshima, MD 0015143819264 guyguytshimakabundi@gmail.com
Contact: Guyguy K. Tshima, MD guyguytshima@yahoo.fr
Listed Location Countries  ICMJE Congo, The Democratic Republic of the
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04537585
Other Study ID Numbers  ICMJE TOMEKA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 18 months
Access Criteria: For free
URL: https://covind.org/
Responsible Party Guyguy K Tshima, MD, University of Kinshasa
Study Sponsor  ICMJE Guyguy K Tshima, MD
Collaborators  ICMJE Centre Médical de Kinshasa (CMK)
Investigators  ICMJE
Principal Investigator: Guyguy K. Tshima, MD University of Kinshasa
PRS Account University of Kinshasa
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP