臨床研究等提出・公開システム

A prospective multi-center open trial to evaluate the safety and efficacy of favipiravir in patients infected with COVID-19.

Favipiravir in patients infected with COVID-19

100

Age, years 62.8 (17.6) Women, n 43 (43.0%) body mass index, kg/m2 26.0 (5.3) Data are presented as the mean (SD).

Cohort 1 was 50 cases, and cohort 2 was 50 cases.

Serious adverse events :10 cases. Adverse events Grade Outcome of SAE Assessment of Causality/Relationship Respiratory Failure Grade5 Death Not related Respiratory Failure Grade5 Death Not related Dyspunea Grade4 Death Not related Exacerbation of pneumonia Grade5 Death Not related Hyperchloremia Grade4 Not recovered Not related Haypernatremia Grade4 Notrecovered Not related Exacerbation of respiratory symptoms Grade4 Not recovered Not related Pnemonitis Grade2 Recovered/resolved Not related Exacerbation of pneumonia shadow Grade1 Recovered/resolved Not related No serious AE (related) occurred AE (related) Cohort 1 CTCAE v5.0 Term Number of cases Number Percentage ALT increased 16 32.0% AST increased 13 26.0% hyperuricemia 13 26.0% creatinine increased 2 4.0% Pruritus 1 2.0% Rash maculopapular 1 2.0% erythema 1 2.0% diarrhea 1 2.0% Sum 48 - Cohort 2 CTCAE v5.0 Term Number of cases Number Percentage ALT increased 9 18.0% AST increased 7 14.0% hyperuricemia 36 72.0% allergic reaction 1 2.0% Pruritus 1 2.0% anorexia 1 2.0% Sum 55 -

There was no difference in adjusted mean change in CRP between cohorts 1 and 2; -1.57 (95% CI -3.02 to -0.12) mg/dL and -2.29 (95% CI -3.77 to -0.81) mg/dL, respectively (p=0.500). The negative conversion rate of SARS-CoV-2 was higher in cohort 2 than in cohort 1 (odds ratio 2.67 (95% CI, 1.09 to 6.52), p=0.032).

There was no difference in adjusted mean change in CRP between cohorts 1 and 2: -1.57 (95% CI -3.02 to -0.12) mg/dL and -2.29 (95% CI -3.77 to -0.81) mg/dL, respectively (p=0.500). The negative conversion rate of SARS-CoV-2 was higher in cohort 2 than in cohort 1 (odds ratio 2.67 (95% CI, 1.09 to 6.52), p=0.032), and a trend of greater efficacy was seen in patients with older age, lower BMI, lower baseline CRP, and without steroid use.

Mar. 31, 2022

No

none

https://jrct.niph.go.jp/latest-detail/jRCTs031190226

Tokue Yutaka

Gunma Universty Hospital

3-39-15 Showa-mchi, Maebashi-shi, Gunma

tokue49@gmail.com

Nakamura Tetsuya

Gunma Universty Hospital

3-39-15 Showa-mchi, Maebashi-shi, Gunma

+81-27-220-8740

nakamurt@gunma-u.ac.jp

Complete

Feb. 27, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

positive result for COVID-19 detection test
fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan
hospital admission

pregnancy
lactation

Both

patients infected with COVID-19

oral administration of favipiravir

Coronavirus

expected value and 95% CI of ratio of C-reactive protein before versus after the treatment

disappearance rate of COVID-19

+81-27-220-8740

Feb. 26, 2020

none