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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guyguy K Tshima, MD
• Collaborator: Centre Médical de Kinshasa (CMK)

Criteria

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.