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A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Influenza Antiviral Drug Avigan Tablet (Favipiravir) in Covid-19 Patients with Non-Severe Pneumonia

Trial Profile

A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Influenza Antiviral Drug Avigan Tablet (Favipiravir) in Covid-19 Patients with Non-Severe Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2020

At a glance

  • Drugs Favipiravir (Primary)
  • Indications COVID-19 pneumonia
  • Focus Therapeutic Use
  • Sponsors FUJIFILM Toyama Chemical
  • Most Recent Events

    • 16 Oct 2020 According to an FUJIFILM Toyama Chemical media release, the company has filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan Tablet to the Ministry of Health, Labour and Welfare in Japan to add an indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan, based on data from this trial.
    • 23 Sep 2020 Results published in FUJIFILM Toyama Chemical Media Release.
    • 23 Sep 2020 According to an FUJIFILM Toyama Chemical media release, the company will conduct a detailed analysis of the data obtained from this study in as early as October.

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

This phase III study is a randomized, placebo-controlled, single-blind comparative study to evaluate the efficacy and safety of Avigan Tablet (favipiravir) in Covid-19 patients with non-severe pneumonia.

Comments

According to an FUJIFILM Toyama Chemical media release, the company has filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan Tablet to the Ministry of Health, Labour and Welfare in Japan to add an indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan, based on data from this trial.

Primary Endpoints

Met on 23 Sep 2020

Time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, and to alleviation of symptoms (body temperature, oxygen saturation and chest images). [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Actual: 156

  • Sex male & female

Patient Inclusion Criteria

−Hospitalized patients showing COVID-19 induced non-severe pneumonia.

Trial Details

Organisations

  • Sponsors FUJIFILM Toyama Chemical
  • Affiliations FUJIFILM Toyama Chemical

Trial Dates

Other Details

  • Design prospective; randomised; single-blind
  • Phase of Trial Phase III
  • Location Japan
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
FavipiravirPrimary Drug Oral Tablet

Avigan Tablet (favipiravir)

placebo

Results

Therapeutic efficacy

The phase III trial met its primary endpoint in which favipiravir significantly reduced time to negative conversion of detectable SARS-CoV 2 viral RNA in COVID-2019 infection patients with non-severe pneumonia. The median time to negative conversion of detectable SARS-CoV 2 viral RNA (a marker of recovery) in favipiravir treated patients were 11.9 days compared with 14.7 days (2.8 days earlier, on average) for the placebo group [p value = 0.0136; adjusted HR: 1.593 (95% confidence interval of 1.024 – 2.479)]. A statistically significant percentage of the patients in the group receiving favipiravir had a rapid reduction in viral loads. Favipiravir also alleviated symptoms related to the viral infection like reduction in body temperature, improvement in oxygen saturation and lesions in chest images. The data were reported from 156 patients. Analysis therby showed patients had a statistically significant higher probability to recover when administered favipiravir compared with the patients not receiving the drug [2] [1] .

Adverse events

In a phase III trial conducted in COVID-2019 patients with non-severe pneumonia (n=156), favipiravir was safe and well tolerated. There were no safety signals were identified in the trial [1] .

Publications

  1. FUJIFILM Toyama Chemical. Anti-influenza drug Avigan(Rm) Tablet Meets Primary Endpoint in Phase III Clinical Trial in Japan for COVID-19 patients. Media-Rel 2020;.

    Media Release
  2. Global Response Aid. Avigan(Rm) Shows Promising Results in Treatment of COVID Patients in Japan. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
FUJIFILM Toyama Chemical 1 1 1
Global Response Aid 1 1 1

Trial History

Event Date Event Type Comment
16 Oct 2020 Other trial event According to an FUJIFILM Toyama Chemical media release, the company has filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan Tablet to the Ministry of Health, Labour and Welfare in Japan to add an indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan, based on data from this trial. Updated 21 Oct 2020
23 Sep 2020 Status change - completed Status changed to completed, according to a FUJIFILM Toyama Chemical media release. Updated 23 Apr 2021
23 Sep 2020 Results Results published in FUJIFILM Toyama Chemical Media Release. Updated 25 Sep 2020
23 Sep 2020 Other trial event According to an FUJIFILM Toyama Chemical media release, the company will conduct a detailed analysis of the data obtained from this study in as early as October. Updated 24 Sep 2020
23 Sep 2020 Results Results (n=156) presented in a FUJIFILM Toyama Chemical media release. Updated 24 Sep 2020
23 Sep 2020 Endpoint met Primary endpoint has been met ( Time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, and to alleviation of symptoms (body temperature, oxygen saturation and chest images)), according to an FUJIFILM Toyama Chemical media release. Updated 24 Sep 2020
02 Apr 2020 New trial record New trial record Updated 02 Apr 2020
31 Mar 2020 Other trial event According to an FUJIFILM Toyama Chemical media release, the company has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug Avigan Tablet(generic name: favipiravir) in Japan for patients of COVID-19. Updated 02 Apr 2020

References

  1. FUJIFILM Toyama Chemical. Anti-influenza drug Avigan(Rm) Tablet Meets Primary Endpoint in Phase III Clinical Trial in Japan for COVID-19 patients. Media-Rel 2020;.

    Media Release
  2. Global Response Aid. Avigan(Rm) Shows Promising Results in Treatment of COVID Patients in Japan. Media-Rel 2020;.

    Media Release
  3. FUJIFILM Toyama Chemical. Fujifilm announces the start of a phase III clinical trial of influenza antiviral drug ##8220##Avigan Tablet##8221## on COVID-19 and commits to increasing production. Media-Rel 2020;.

    Media Release
  4. FUJIFILM Toyama Chemical. Fujifilm Filed an Application for Partial Changes to the Manufacturing and Marketing Approval Matters of Anti-Influenza Drug Avigan(Rm) Tablet in Japan to Include Additional Indication for COVID-19. Media-Rel 2020;.

    Media Release
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