“The main objective of the study, reducing deaths and severe symptoms of Covid-19, has not been achieved. Only a secondary objective has been presented, that the drug is capable of reducing viral load. This, in practice, does not solve the problem of coronavirus “, said epidemiologist Paulo Lotufo.
Virologist Anderson Brito, from the epidemiology department at the School of Public Health at Yale University in the United States, explains that viral load is an approximate measure of the amount of virus in a sample extracted from the patient. “This measure is made by measuring the amount of genetic material of the virus per mL”, he says.
“In severe cases, there are studies showing an association between viral load and risk of death. This is not the case in this study, which focused on mild cases of Covid”, explains Brito.
Infectologist Alberto Chebabo, who also read the article, estimates that the drug was not able to reduce severe symptoms of Covid-19.
“The article did not demonstrate that nitazoxanide is capable of reducing the risk of death or serious outcomes, such as the need for oxygen and progression to a mechanical respirator. It only decreased the occurrence of fever and lowered the viral load. That is very little for the severity of the disease. “, says Chebabo.
The article with the results was published in a pre-print version on the medRxiv platform and is still being evaluated by a scientific journal. According to the publication, nitazoxanide reduced viral load in patients with mild symptoms and decreased fever.
“It is a job well done, which shows that the drug has an antiviral activity, which was to reduce the viral load, but we do not know what that means in practice, it needs more research. It is not possible to say that it decreased the risk of contagion only by decreasing viral load and that you no longer need to isolate “, explains Chebabo.
Volunteers received a kit with nitazoxanide for a clinical study in Bauru, one of the cities that participated in the Ministry’s study. – Photo: Alisson Negrini / TV TEM
The study was coordinated by researcher Patricia Rieken Macedo Rocco, from the Federal University of Rio de Janeiro (URFJ), who participated in the federal government ceremony to publicize the research. (See below)
Asked if it makes sense, according to what was shown in the article, nitazoxanide to join the treatment protocol of Covid-19, Chebabo says no, and compares the drug with the antiviral remdesivir.
“The effects pointed out in the treatment with nitazoxanide are minimal, it does not justify mass production and adoption in treatments. However, it has antiviral activity, so it can be further studied”, he says.
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“By way of comparison, it is much better than chloroquine, which is expensive and has no effect. Or, we can compare it with remdesivir, which has some effect, but has no impact on serious cases and decreasing deaths,” he compares. Chebabo.
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On Monday (19), the Minister of Science, Technology and Innovation, Marcos Pontes, together with President Jair Bolsonaro, announced the conclusion of the study in question and just said, without showing data, that the drug had “positive results” .
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Without giving details of the results or presenting the study in its entirety, the government reported that clinical trials with volunteers showed that the drug reduced viral load when it was taken within 3 days after the onset of symptoms.
According to the government, the work had been submitted for analysis by a scientific journal and, therefore, the ministry cannot give details of the results.
During the ceremony, the government presented a video that shows the trajectory of the research. In it, the organizers displayed a graph without data, identical to the one available in the image bank service ShutterStock.
The images are displayed when the narrator states that “the mission given to the Ministry of Science, Technology and Information has been accomplished” and “the result has scientifically proven the effectiveness of the drug in viral load.”
Video screen presented at the ceremony of the Ministry of Science and Technology. Base and data are identical to those available at ShutterStock agency. – Photo: Playback / TV Brasil
Below, the image available in the image bank:
Graphic sold by ShtterStock and which is identical to the one used in a ceremony of the Ministry of Science and Technology to show the efficacy of vermifuge against Covid .. – Photo: Reproduction
Wanted by G1, MCTIC’s press office reported that “the graphic used in the video presented at the announcement event of the results of clinical trials with nitazoxanide is not part of the study data and appears only for illustrative purposes”.
Nitazoxanide is a drug used in the country by the trade names Azox and Annita and is part of the group of antiparasitic and wormers. The drug also has antiviral action and is prescribed in cases of rotavirus.
To avoid self-medication, the drug started to be sold only with a prescription in April this year. However, a decision by the National Health Surveillance Agency (Anvisa) of September 1 removed the requirement to retain revenue. The drug containing nitazoxanide, commercially available, has no indication for the coronavirus, according to the World Health Organization (WHO).
According to the minister, more than 1,500 volunteers from seven cities in the Federal District, São Paulo and Rio de Janeiro participated in the clinical study. They were divided into two groups: one took nitazoxanide and the other took a placebo. According to the government, the group that received the medicine, a vermifuge, showed a decrease in viral load.
“Him [nitazoxanida] it is low cost, it has no important side effects, ”said Pontes. “Nitazoxanide cannot be used to prevent [da Covid-19]”, Added the minister.
President Jair Bolsonaro and First Lady Michele Bolsonaro participated in the presentation ceremony of the research’s first conclusions.
“There was a significant reduction in viral load in this group,” said the study’s general coordinator, Patrícia Rieken Macedo Rocco, head of the Pulmonary Research Laboratory at the Carlos Chagas Filho Biophysics Institute (IBCCF) at the Federal University of Rio de Janeiro (UFRJ) .
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