Preliminary clinical results of Fapilavir in the treatment of COVID-19 are available! Eliminates virus in 4 days with good safety and tolerance.
Preliminary clinical results of Fapilavir in the treatment of COVID-19 are available! Eliminates virus in 4 days with good safety and tolerance.
A "Clinical Study on the Safety and Effectiveness of Fapilavir in the Treatment of Patients with New Coronavirus Pneumonia (COVID-19) (Registration Number: ChiCTR2000029600) which was mentioned in the press conference of the scientific research group of the joint prevention and control mechanism of the Science and Technology Ministry came out.
Research suggests that favipiravir may relieve the progression of COVID-19 by accelerating virus clearance. The research was completed by the group of Liulei and Liu Yingxia from the National Engineering Research Center for Emergency Prevention and Control and the Third People's Hospital of Shenzhen City.
Viral clearance is the main internationally accepted standard for evaluating clinical efficacy of antiviral drugs. In the "Clinical Study on the Safety and
Effectiveness of Fapilavir in the Treatment of Novel Coronavirus Pneumonia (COVID-19) Patients (Registration No.: ChiCTR2000029600)", 35 patients with common COVID-19 who met the eligibility criteria were accepted Favipiravir treatment (3200 mg on the first day, 1200 mg/d on the 2nd to 14th days, divided into two oral doses, and the course of treatment lasts until clearing the virus or the 14th day).
The study also included 45 patients with COVID-19 who were treated with lopinavir / ritonavir tablets (400mg/100mg, twice daily, orally) matching age, gender, and disease severity as the control group. Comparing the median time from taking drugs to virus clearance, chest radiographic improvement rate and safety on 14th day of treatment were compared between the two groups.
The results showed that all baseline characteristics of the two groups of patients were comparable. The median time of virus clearance was shorter in the Favipiravir treatment group, with a median (interquartile range) of 4 days (2.5-9 days) and a control group of 11 days (8-13 days), with significant differences between the two groups ( P <0.001).
After controlling potential confounding factors (age, onset time, fever, etc.), Favipiravir remains an independent influencing factor for improved chest imaging and early virus clearance. Compared with the control group, the favipiravir group had fewer adverse reactions with better tolerance. The research results have been submitted to the journal of the Chinese Academy of Engineering.
What is Fapilavir?
Fapilavir is one of three drugs focused by the scientific research group.
It is also known as Favilavir or Avigan, developed by Toyama chemical co., Ltd. in Japan.
This is an experimental anti-influenza drug, belonging to the broad-spectrum anti-RNA virus drug, with activity against many RNA viruses. In 2014, it was approved in Japan as a stockpile for anti-flu pandemic.
Previous trials have shown that fapilavir has a certain effect on Ebola virus.
Results from tests in 2015 showed that it could reduce mortality in patients with low to moderate blood levels of Ebola virus.
Fapilavir also effectively inhibits Ebola virus, yellow fever virus, Chikungunya virus, and norovirus. The latest study showed that in vitro cell line experiments, its EC50 against neocrown virus reached 61.88 μM.
In subsequent clinical trials of COVID-19, fapilavir gradually showed its efficacy.
The participating Shenzhen Trinity Hospital disclosed a conclusion that Fapilavir is safe and effective, whose antiviral effect is better than that of clitorid, and its side effects are also significantly lower than that of clitorid. It is recommended to expand the scale in clinical application.
On February 15, at the press conference of the joint prevention and control mechanism of the State Council, Zhang Xinmin, director of the Biological Center of the Ministry of Science and Technology, further revealed the clinical results:
Fapilavir is an overseas marketed drug for the treatment of influenza. which were going thorugh clinical trials in Shenzhen. More than 70 patients have been enrolled, including the control group, which has initially shown more obvious efficacy and lower adverse reactions. From 3 to 4 days after treatment, the viral nucleic acid conversion rate in the treatment group was significantly higher than that in the control group.
On the same day, Fapilavir was formally approved for marketing by the State Drug Administration, becoming the first drug in the country to have a potential therapeutic effect on COVID-19 during the epidemic.
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