Nitazoxanide against COVID-19: two pilot tests on the antiparasitic drug advance in the country

This drug, a synthetic derivative of sialicylamide, is effective against a wide variety of parasites and bacteria (Shutterstock)

Nitazoxanide is a 5-nitrothiazole with broad spectrum antiparasitic and antibacterial activity. This drug, a synthetic derivative of sialicylamide, is effective against a wide variety of parasites and bacteria, many of which cause symptoms such as diarrhea and other ailments, which infect both animals and humans and is administered through tablets or by liquid suspension.

However, in the race to find new treatments that can help reduce the worsening of symptoms of COVID-19, the virus that has already caused almost 148 million infections worldwide and caused the death of 3.1 million people, according the latest data from the Johns Hopkins Medicine & University Resource Center, this drug could be used to treat coronavirus patients.

La nitazoxanida It is a known drug in the world, which has few adverse effects, generally mild and temporary, of the gastrointestinal type. The medication works mainly by inhibiting the expression of a viral protein called ‘N’ and also would suppress the production of pro-inflammatory cytokines, believed to be involved in the COVID-19 disease process.

“Nitazoxanide is an antiparasitic that has been used for a long time for different infections caused by parasites, but it has also been used successfully in different respiratory viral infections, such as influenza, such as MERS and also at the clinical research level in viral hepatitis ”, explained in dialogue with this medium Marcelo Silva, boss Hepatology of the Austral University Hospital.

Nitazoxanide was tested against a wide range of parasites, including protozoa, nematodes, cestodes, and trematodes, to support clinical evaluation in humans (REUTERS)
Nitazoxanide was tested against a wide range of parasites, including protozoa, nematodes, cestodes, and trematodes, to support clinical evaluation in humans (REUTERS)

Recently, the American laboratory Romark, based in Tampa, Florida, announced the initial results of a clinical trial Phase III of your new drug candidate, nitazoxanide, investigational NT-300 (nitazoxanide extended-release tablets, 300 mg) versus placebo as a treatment for moderate COVID-19. Based on the findings, Romark is working with the United States Food and Drug Administration (FDA) to request an emergency use authorization in that country.

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Today, this antiparasitic it is used mostly in adults, although it can also be used in children, to treat infections with parasites such as ascaris and giardia lamblia. The latter produces symptoms, which usually appear one to three weeks after exposure to the disease, and can include diarrhea, fatigue, stomach cramps and bloating, gas, nausea and weight loss. Mayo Clinic.

It is a very good and effective antiparasitic against protozoa and intestinal worms; the possibility of testing it in this pandemic arose some time ago ”, he commented consulted by Infobae the epidemiologist Hugo pizzi. Is that, according to the specialist, this drug was tested during the epidemic of MERS-CoV, a viral respiratory disease that began in April 2012 in the Middle East, caused by another coronavirus. “The MERS virus is a cousin of this coronavirus and also, at the time, it was tested in upper airway pathologies and flu symptoms. With MERS, cytokines responsible for the inflammatory condition decreased”He added.

Nitazoxanide was tested against a wide range of parasites, including protozoa, nematodes, cestodes and trematodes, to support clinical evaluation in humans. “It has been used for a long time to treat parasites or intestinal infections.. The study is in Phase III and the results will show its effectiveness or not. It would change the course of the disease and avoid exacerbations. But it is not yet known. It is something similar to what happened with ivermectin ”, he shared with Infobaemeanwhile, the pediatrician Carlos Kambourian.

Studies in Argentina

In two local studies, volunteers are being recruited to find out if the drug commonly used for the treatment of parasitic, bacterial and viral infections would also serve to prevent the transmission of the COVID-19 virus or prevent the mild infection from becoming more serious (REUTERS )
In two local studies, volunteers are being recruited to find out if the drug commonly used for the treatment of parasitic, bacterial and viral infections would also serve to prevent the transmission of the COVID-19 virus or prevent the mild infection from becoming more serious (REUTERS )

Nitazoxadine is being investigated in Argentina with promising results in a pilot clinical study with 135 patients with a confirmed diagnosis of COVID-19 Y mild to moderate symptoms. Work, which is published on the international site Clinical Trials, is being carried out in the Austral University Hospital and in the Clinic of the Pilar de Ciudadela, both in the Province of Buenos Aires.

Silva, together with his Clinical Research team, he had started a efficacy and safety study of this drug in the treatment of patients with SARS-CoV2 virus infection (COVID-19) with mild or moderate symptoms in the middle of last year. The main objective of the research was to evaluate whether the drug prevents the progression of the disease to stages where hospitalization with intensive care is required.

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In dialogue with Nelson Castro in “Chronicle of an Announced Afternoon”, the expert provided details on the reports they are doing with the drug. In the pilot clinical study being carried out at the Austral University Hospital, the institute’s head of Hepatology, the expert assured that “50% of the patients treated with Nitazoxanide had a decrease in viral load on day seven greater than 35% while those treated with placebo only 10% had this result.”

“In their vast majority, these antivirals, especially those that are replacement drugs, they are used in early stages of the disease and in patients with not very severe disease ”, said the specialist. And he completed: “We want to finish recruiting the 135 patients to confirm the data we have so far.”

“The mechanism of action of nitazoxanide is not definitively elucidated but, somehow, preclinical studies support that it induces the immune response in patients mediated by interferon” (REUTERS)

In order to Silva, “The mechanism of action of nitazoxanide is not definitively elucidated but, somehow, preclinical studies support that it induces the immune response in patients mediated by interferon; from the point of view of its antiviral activity, it has been demonstrated in different preclinical settings and our study is the one that demonstrates that a significant drop in viral load can be seen in patients ”.

“But there is another more important study still, which is one carried out in Brazil, with a significant number of patients: on day 5, the rate of patients who were negative for COVID-19 was much higher for those who had been treated with nitazoxanide versus those who received placebo”, He added.

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Another study in the country is the one that carries out the Guest Foundation. There, the team in which he participates Herman Ludvik, of the Infectology Division of the Fernandez Hospital and a member of the foundation’s research area, investigates whether the nitazoxanida can prevent infection in the close contacts of a person with COVID-19. For that, they are summoning volunteers who are cohabiting of confirmed cases. The number to be gathered is 456 volunteers: one group receives the treatment and the other a placebo. They are already studying 140 volunteers.

This medication, as noted Lace, in studies in vitro -that is, in cellular tissues in the laboratory- demonstrated a good range of efficacy against the SARS-CoV-2 coronavirus. The drug, available in Argentina, is a synthetic derivative of sialicylamide, used as a broad spectrum antiparasitic agent with proven effectiveness in protozoan and worm infections. It is approved for infections by parasites such as cryptosporidium parvum and giardia lamblia in patients older than one year.

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