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Glenmark enrols 150 patients to test favipiravir, the ‘most sought-after drug for Covid’

The dosage frequency of the tablets will be 1,800 mg twice on first day, 800 mg twice on second day, which will then be followed for up to a maximum of 14 days.

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New Delhi: Mumbai-based drug maker Glenmark has enrolled 150 Covid-19 patients to conduct a clinical study of the Japanese flu drug favipiravir, which has emerged as a possible treatment measure against the Covid-19 infection.

Last month, the company announced that it has received an approval from the Drug Controller General of India to conduct clinical trials of the antiviral tablets.

Glenmark is the first pharmaceutical company in India to test favipiravir, one of the most sought-after drugs for Covid-19 treatment, the pharma company said in a press statement issued Tuesday, adding that “over 9 leading government and private hospitals in India are being enrolled for the study”.

“Trial completion and study results expected by July or August 2020,” the company added. 

A senior official from Glenmark told ThePrint: “We will start giving the doses shortly for the course of treatment.”

Glenmark has successfully developed the active pharmaceutical ingredients (API) and the formulations for the product through its in-house research and development team. 

Favipiravir is an antiviral medication that was initially developed to treat influenza in Japan. In February, it was studied in China and other countries as an experimental treatment of Covid-19. 

It is among the top drugs under trial for Covid-19 treatment along with the anti-malarial medicine chloroquine, Ebola drug remdesivir, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of the latter two drugs infused with Interferon beta.

The drug is a generic version of Avigan (brand name) of Fujifilm Toyama Chemical, a subsidiary of Fujifilm Corporation, which manufactures favipiravir.


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The trial

The clinical study of favipiravir will be done along with the standard supportive care in Covid patients with mild to moderate symptoms.

It will be a randomised, multi-centre study that will be conducted at the Covid-19 wards of All India Institute of Medical Sciences in Chhattisgarh, apart from six hospitals in Maharashtra and two in Gujarat.

The sample size of the study is 150 patients, who will be given favipiravir’s oral tablets. The dosage frequency will be 3,600 mg (1,800 mg twice) on the first day followed by 1,600 mg (800 mg twice) on the second day, which will be followed for up to a maximum of 14 days.

The primary objective of this study, according to the Clinical Trials Registry-India (CTRI) website, is to “evaluate the clinical efficacy of favipiravir combined with standard supportive care compared with standard supportive care alone”.

It further added: “The study includes 3 days of screening period and maximum 14 days of the treatment period. The total duration of study participants will be a maximum of 28 days from the day of randomisation.”

Shown efficacy in an earlier trial

According to a report published in The Guardian in March, doctors in Japan used the drug in clinical studies on Covid-19 patients with mild to moderate symptoms.

The report quoted Zhang Xinmin, an official in China’s science and technology ministry, as saying: “Favipiravir, developed by a subsidiary of Fujifilm with brand name Avigan, had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.”

“It has a high degree of safety and is clearly effective in treatment,” Xinmin said.

The use of favipiravir showed definite improvements in lung condition in 91 per cent of the patients treated with it, compared to 62 per cent of those treated without the drug, the report added.  

The drug, however, did not show great results on patients with severe symptoms.


Also read: Alternate medicine manufacturers claiming Covid-19 cure could face year in jail


 

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