Institute of Chemistry (Vietnam Academy of Science and Technology) successfully researched and synthesized Nitazoxanide compounds to produce COVID-19 medicine from cheap raw materials

21/12/2021
Recently, Institute of Chemistry (Vietnam Academy of Science and Technology) has successfully synthesized Nitazoxanide compounds at pilot scale to produce medicine to treat COVID-19 in mild and moderate patients. The success of Institute of Chemistry contributes to the joint efforts of Vietnamese scientists in researching medicines, vaccines and biological products for the prevention and control of COVID-19 pandemic.

Following the direction of Prime Minister in Resolution 78/NQ/CP on July 20, 2021, President of VAST assigned Institute of Chemistry and Institute of Marine Biochemistry to implement the unexpected task of synthesizing a number of potential medicines for COVID-19 treatment.

In addition to Favipiravir (researched by Institute of Chemistry) and Molnupiravir (researched by Institute of Marine Biochemistry) which have been reported to have been successfully synthesized in the past, Institute of Chemistry continues to research and gain success in perfecting the process of synthesizing Nitazoxanide at pilot scale. Nitazoxanide synthesis process achieves high efficiency through only two reaction steps from low cost raw materials. This is a generic medicine with a very cheap price, used orally, safe and suitable for use in Vietnamese conditions.

Some photos of the synthesis of Nitazoxanide at Institute of Chemistry

Nitazoxanide has broad-spectrum antiviral activity against many different viruses. Particularly active against SARS-CoV-2 cultured on verocell6 with IC50 2 µM. In addition, Nitazoxanide has the ability to enhance immune response, improve the lungs and damage on many organs, so this medicine can be used effectively in the treatment of COVID-19 patients with comorbidities, especially the cytokine storm.

On 11/11/2021, Institute of Chemistry and Kassell Vietnam Company signed a contract in principle to transfer technology and propose to apply for a clinical trial of Nitazoxanide for the treatment of mild and moderate COVID-19 patients at home.

Currently, the world has been conducting 29 clinical trials on COVID-19 patients, of which 8 have ended, proved that Nitazoxanide can be used safely for early treatment of COVID-19 in mild and moderate form, reducing viral load and reducing the number of patients hospitalized. Nitazoxanide has also been shown to be effective for the treatment of pregnant patients and for prophylactic use by healthcare professionals.

It is noteworthy that the results of Romark Company's phase 3 clinical trial of Nitazoxanide, a randomized, double-blind, placebo-controlled trial at 36 centers, were reported in 379 patients (including 37% mild and moderate patients, 60.9% severe patients) with a dose of 600 mg divided into 2 doses for 5 days.

The results demonstrated that Nitazoxanide had the ability to reduce by 85% COVID-19 patients hospitalized and worsened compared to the control group [1/184 (0.5%) using Nitazoxanide compared to 6/195 (3.1%) receiving placebo, p=0.07]; average time to sustainable recovery is 3.1 days; time to return to normal was reduced by 5.2 days compared to placebo. The medicine is safe to use and has good tolerability. 

According to the assessment of Romark Company, this medicine has an activity equivalent to the monoclonal antibodies that have been approved by FDA for the treatment of COVID-19 disease. On April 14, 2021, Romark Company submitted an application to US FDA for a license to use Nitazoxanid NT 300 orally for treatment of mild and moderate COVID-19 patients.

Translated by Phuong Ha
Link to Vietnamese version

 

 



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