COVID-19: Favipiravir (Avigan) Clinical Research Results: For Mild Inpatients
Fujita Medical University:
Since March 2020, “Avigan” has been “administered to 88 mild and asymptomatic inpatients” to conduct clinical studies to confirm its efficacy and safety.
On July 10, we announced the results at an online conference.
Clinical research:
comparing and checking.
“Group receiving Avigan for up to 10 days from the first day”
“Group not administered for the first 5 days and administered after the 6th day of hospitalization”
Research results:
“Group administered from day 1”
By day 6, 66.7% of patients had no detectable virus
“Group not administered for 5 days from the first day”
By day 6, 56.1% of patients had no detectable virus
Average number of days it took for the fever to drop:
2.1 days after administration from the first day,
3.2 days if not administered for 5 days,
There was a tendency for the virus to disappear and the fever to fall more easily after administration on the first day of hospitalization.
However, he said that the statistically clear effectiveness could not be confirmed.
The serious side effect is that it could not be confirmed.
Ministry of Health, Labor and Welfare:
It depends on “the decision of the pharmaceutical company whether to apply“.
Ministry of Health, Labor and Welfare
How to handle this result,
Whether to apply for therapeutic approval in the future
Is a decision of a pharmaceutical company.FUJIFILM:
“Examine the content of the presentation and continue the clinical trial”
FUJIFILM is proceeding with clinical trials aiming for national approval as a therapeutic drug for COVID-19.
Regarding the results of the clinical research at Fujita Medical University:
Fujifilm is
We will scrutinize the contents of the Fujita Medical University presentation.
The original clinical trials conducted as a company are still ongoing,NHK news
https://www.google.co.jp/amp/s/www3.nhk.or.jp/news/html/20200710/amp/k10012508371000.html
About the final report of favipiravir (Avigan) specific clinical study
Fujita Medical University
Conducted at 47 medical institutions nationwide with Fujita Medical University as the representative institution
Randomized clinical trial for asymptomatic and mild patients
A preliminary multi-center, open-label, randomized clinical trial of favipiravir in asymptomatic and mild patients with SARS-CoV2 infection has been provisionally analyzed.
Target of this study
A total of 89 COVID-19 patients participated in this study from early March to mid-May.
Normal administration group
Forty-four people were given favipiravir normally (from the first day on oral administration),
Delayed administration group
45 patients were randomly assigned to the delayed treatment group (oral administration from day 6).
Last dose
Excludes 19 people who were found to have already lost the virus at a later date.
This was performed by 36 patients in the normal administration group and 33 in the delayed administration group.
No one has died or died while participating in the study.
Main evaluation items
“The cumulative viral elimination rate up to the 6th day (until the delayed administration group starts oral administration)” is
66.7% in the normal administration group,
56.1% in the delayed administration group,
Adjusted hazard ratio is 1.42 (95% confidence interval = 0.76-2.62, P value = 0.269)
Secondary evaluation items
“The viral load logarithm 50% reduction rate by the 6th day” is
94.4% in the normal administration group,
78.8% in the delayed administration group,
Adjusted odds ratio is 4.75 (95% confidence interval = 0.88-25.76, P value = 0.071)
Exploratory evaluation items
“Average time to fever below 37.5℃”
2.1 days in the normal administration group,
3.2 days in delayed dose group,
Adjusted hazard ratio is 1.88 (95% confidence interval=0.81-4.35, P value=0.141)
Adverse event
84.1% increase in blood uric acid level,
11.0% increase in blood triglyceride level,
Liver ALT elevation is 8.5%,
Elevated liver AST (both abnormal test values) 4.9%
Final evaluation
From the above,
Compared to the delayed administration group in the normal administration group
By the 6th day, there was a tendency that the virus disappeared and fever was easily released.
However, it did not reach statistical significance.
Fujita Health University