After completing all the steps before the National Institute of Food and Drug Surveillance, Invima, the Cartagena doctor Carlos Riveros and his team would begin next Tuesday, January 19, the human tests of their treatment against COVID-19, in the framework of a study endorsed by Invima himself.
The study, which is carried out at the clinic of Dr. Juan Haller, in Barranquilla, will start with 60 patients: people who have tested positive for COVID-19, but are in the initial stages of the disease. This, as Dr. Riveros himself has explained, is due to the fact that the objective of the treatment is to prevent the virus from passing from the upper respiratory tract (the nose, nasal cavity, mouth, throat -pharynx- and larynx) to the lower ones (trachea, bronchi and bronchioles and alveoli, which form the lungs), with which the patients would not become complicated or hospitalized for COVID-19. The treatment consists of a series of nebulizations, through which patients receive an anti-inflammatory and an antiviral that, together, according to the doctor, could reduce the replication capacity of the virus and, consequently, the viral load. (You may be interested in: The nebulizations that would combat COVID-19)
“Currently, a team of three doctors and five nurses, Barranquilla, with whom a test will begin to develop the 60 patients necessary to meet the number required by Invima to obtain the significant statistical result and demonstrate, in the brevity, the efficacy and effectiveness of the drug in the initial stage of the disease, “explained Dr. Riveros’ team in a press release. They also highlight that, to date, in clinical observations, there are 456 cases that have successfully overcome the disease.
What will happen to those patients?
The 60 people newly diagnosed with COVID-19, positive without symptoms or with mild symptoms, will receive a treatment consisting of 5 days of nebulizations and follow-up through telemedicine. At this time, viral loads and subgenomic messenger RNA will be measured.
It must be said that it is a “randomized randomized study, which means that we will have 60 patients (…), what we will do is that 30 of them will receive the treatment and the other 30 a placebo, it is It is important to clarify that all patients, of all groups, will receive parallel treatment indicated by the protocols that their doctors use -as he explained to The universal Dr. Riveros-. It is a double-blind study, that is, we do not know, the patient does not know if he is receiving our treatment or the placebo, and we do not know either “until the end of the study, when the envelopes with the information of each patient are opened and the information is going to be analyzed. (See also: [Video] Anti-COVID treatment developed by Cartagena, to phase 2)
What will happen at the end of the human study?
If everything goes as the Riveros team expects it, the results of the investigation will be ready to analyze in about ten days after starting, in January the study could be massed, that is, a phase 3 with many more patients, or , “If permitted by law, in an emergency circumstance, also begin to distribute it freely, so that anyone, anywhere in Colombia could use it, only with the onset of symptoms or the suspicion of being infected”, concluded the doctor.
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