Carvativir is science and humanity with a designation of origin

Any Venezuelan grandmother can attest to the healing properties of thyme. Its use as a condiment is widespread throughout the world, but also, depending on the disease, in infusion, powder, oil or consumed directly from the plant, it offers relief from various ailments; it is anti-inflammatory, antiseptic, antidiarrheal, bronchodilator and even fungicidal. The Egyptians knew of its power, who used it among the antibacterial mixture that helped them embalm their mummies, and today modern pharmaceutical companies use it in at least ten commercially used drugs, according to the Vademecum.

The therapeutic capacity of thyme has been on the lips of many people this week when the presentation of the drug Carvativir, a broad-spectrum antiviral with Venezuelan stamp, capable of attenuating the symptoms of covid-19 and therefore contributing to a faster recovery and even to survival. The essential oil of this plant is its raw material through a phytochemical compound that is also found in oregano: isothymol, in turn placed in squalene, which works as an excipient.

The history of Carvativir began in silence nine months ago, with preclinical trials and clinical studies in patients with mild, moderate and critical symptoms, in sentinel hospitals and in the Poliedro de Caracas. To ensure reliable research results, it was tested at different stages in laboratories in Venezuela, Turkey and the United States. What was discovered more than met expectations and now the country makes this discovery available to the world under the universal precept of solidarity. Let's delve into this history of science and innovation with a Venezuelan stamp.

Antivirals against coronavirus

Although the development of vaccines against covid-19 has been making headlines for a year, work on formulating antiviral treatments to alleviate the effects of the disease has been less blockbuster news.

At the beginning of the pandemic, drugs already approved for other infections sounded, which according to the scientific community could be effective treatments against this new virus. Chloroquine, originally used against malaria and some autoimmune diseases such as lupus or rheumatoid arthritis, appeared as a promising option; also Remdesivir, a broad spectrum antiviral that is in the clinical trial phase against Ebola. Today both drugs do not have the approval of the WHO with regard to the treatment of the coronavirus.

Another drug is Favipiravir, developed in Japan and approved to treat the flu, from which in turn two Russian-label drugs were born: Avifavir and Coronavir.

As a new drug, this week, in parallel with the announcement of Carvativir, Aplidin was presented in Spain, an antiviral drug made from plitidepsin, isolated from a species of sea squirt called aplidium albicans, which is found in shallow waters. of all the world. This antiviral bears the seal of the PharmaMar laboratory and, they say, reduces the viral load of SARS-Cov-2 by almost one hundred percent.

But unlike the Venezuelan drug, Aplidin has only been tested in two mice, it has not had clinical tests, ergo, its effectiveness in humans is unknown. In this context, the Venezuelan drug appeared.

Carvativir, a world-class scientific effort

Carvativir is produced by Labfarven, Laboratorio Farmacológico de Venezuela CA, and its development was a collective delivery by the Ministry of Science and Technology, the Ministry of Health, the Venezuelan Institute of Scientific Research (Ivic), the Rafael National Institute of Hygiene Rangel and the National Service of Medicine and Forensic Sciences.

The details of this Venezuelan medical innovation are systematized in scientific reports that are awaiting publication in specialized international journals. The drug will be delivered to the World Health Organization (WHO) with the results of the antiviral efficacy and the mechanism of action of the compound isothymol for its respective international certification.

According to the global summary of the investigation, the patent had an approval in formal examination on December 14, 2020. Prior to that, in its preclinical phases of testing, the drug had the in vitro (Petri dish), developed by the Venezuelan Institute of Scientific Research (IVIC) and Laboratorios Carmed (Turkey), which consisted of a test carried out in mice, while the in silico test (test with computer models), was carried out by Autodock Vina (Venezuela), which developed the molecular simulation model.

The report states that clinical phases I and II were carried out between June and July 2020. One hundred patients participated in the clinical trial and safety and dosage were measured.

In this clinical study on the antiviral and immunomodulatory activity of the recombined isothymol compound against the SARS-CoV-2 agent in covid-19 patients, researchers from the R&D Department, J&R Drugstore, Venezuela Pharmacological Laboratory (Labfarven), Hospital Dr. Domingo Luciani and the National Service of Medicine and Forensic Sciences (Senamecf).

In phase III (August-November 2020), the multicenter, randomized, double-blind clinical trial was carried out with placebo (a tool of the scientific method used to prevent the results of an investigation from being influenced by the placebo effect), with the participation of 600 patients. Of this number, half with isothymol (experimental phase) and half with placebo (control phase).

The Bioethics Committee of the Hospital Universitario Periférico Dr. Miguel Ángel Rangel measured the safety, tolerability and antiviral and immunomodulatory activity of the compound. They indicated that in the clinical and preclinical tests performed on the patients are: Complete hematology, Dimero D, Ferritin, Fibrinogen, PT and PTT, IgM, IgG, IL-6, C-reactive protein (CRP), chest X-ray, CT and RT-PCR, which were processed in the Immuno XXI laboratories (Caracas, Venezuela) and Mayo Clinic (Minnesota, USA).

Likewise, the report states that additional tests were carried out on the accelerated stability and the microbiological study of isothymol (Carmed, Turkey) and gas chromatography with mass spectrometry, as well as the infrared absorption spectroscopy FT-IR, in charge of the IVIC .

Carvativir saves lives

In simple words, the Venezuelan drug saves lives because by tackling the symptoms of the disease it does not allow the patient to get worse to the point of no return. It was explained by Raúl Ojeda Rondón, the principal investigator of the project that designed the Carvativir, in recent statements.

“Carvativir presents scientifically, with evidence, a therapeutic action. (…) Carvativir reduces hospital recovery time because it accelerates the immune response. That's part of the Venezuela findings. It was determined that it has antiviral therapeutic activity. The molecule inhibits viral replication in human cells. The viral load is decreasing. It also enhances immunomodulatory powers. It diminishes, what we call in medicine the cytokine storm, which is nothing more than the exaggerated response of the immune system, what is known as lung inflammation through atypical pneumonia due to covid-19. That's where the intubation process comes in, ”he highlighted.

Now comes phase IV of the drug, which is mass production and pharmacovigilance. The scientific team that built this achievement is inviting the WHO to Venezuela to certify it. "We are going to open ourselves to all the scientific communities of the country and abroad so that they can see what we have obtained up to today," he said.

Everything was ratified by President Nicolás Maduro when he officially presented the Venezuelan discovery: “The Carvativir passed all the studies; it already has patents and sanitary registration in our country. This drug has been shown to be XNUMX% effective against the virus. " Carvativir will be distributed throughout the national public system for the treatment of the pandemic virus and constitutes a medical advance that Venezuela wants to share with the world for the joint fight against the new disease that until now has not given respite.