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

NCT04537585 | Unknown DMC

• 1 other identifier: TOMEKA
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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 Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their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.

Conditions

Covid19

Keywords

Covid 19; Tomeka®; Vernonia amygdalina; Selenium; DRC

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-TOMEKA® usage

  process assessed by Education

  18 months

Secondary Outcomes (1)

• Change From Baseline in herbs Vernonia amygdalina usage

  18 months

Study Arms (2)

Tomeka

EXPERIMENTAL

Number of participants with treatment-TOMEKA® usage as assessed by Education \[ Time Frame: 18 months \] Change people's behaviour

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

Combination Product: Tomeka®; Drug: "Vernonia amygdalina"

Interventions

Tomeka® COMBINATION_PRODUCT

Tomeka® is a farine mixte made by soy, sorghum, maze and mushrooms

Also known as: Maze, Soy, Sorghum, Mushrooms

"Vernonia amygdalina"; Tomeka

"Vernonia amygdalina" DRUG

"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).

Also known as: Congo Bololo (D. R. Congo), grawa (Amharic), ewuro (Yoruba), etidot (Efik), onugbu (Igbo), ityuna (Tiv),, oriwo (Edo), Awɔnwono (Akan), chusar-doki (Hausa),

"Vernonia amygdalina"; Tomeka

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• COVID-19 patients confirmed
• be regular on appointments
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guyguy K Tshima, MD: lead
• Centre Médical de Kinshasa (CMK): collaborator

Study Sites (1)

Cliniques Universitaires de Kinshasa

Kinshasa, BP KIN XI, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

COVID-19

Interventions

MAZE protocol; Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Guyguy K. Tshima, MD

  University of Kinshasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guyguy K. Tshima, MD

CONTACT

0015143819264; guyguytshimakabundi@gmail.com

Guyguy K. Tshima, MD

CONTACT

guyguytshima@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months
• Access Criteria: For free

Locations

DE (1)