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Multicenter, Adaptive, Randomized, Placebo-Controlled, Comparative Study to Evaluate the Efficacy and Safety of Favipiravir in Patients with COVID-19 Non-Severe Pneumonia

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Trial Profile

Multicenter, Adaptive, Randomized, Placebo-Controlled, Comparative Study to Evaluate the Efficacy and Safety of Favipiravir in Patients with COVID-19 Non-Severe Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2022

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At a glance

  • Drugs Favipiravir (Primary)
  • Indications COVID-19 pneumonia
  • Focus Registrational; 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 adding favipiravir to the standard treatment for pneumonia exceeds that without favipiravir in patients with COVID-19 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]

Other Endpoints

Safety:Adverse events
Efficacy:Change in patient condition on a 7-piont scale [2]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 96

    Actual: 156

  • Sex male & female
  • Age Group 20-74 years; adult; elderly

Patient Inclusion Criteria

1 Age: 20 to 74 years inclusive2.Sex: No restriction3 Out patient/hospitalization: Hospitalization4 Laboratory (RT-PCR) confirmed infection with SARS-CoV-2.5 Lung involvement confirmed with chest imaging6 Patients with fever of 37.5 degrees Celsius or more7 Have a negative pregnancy test before study treatment8 Others

Patient Exclusion Criteria

1 Ten days or more have passed since the fever (37.5 degrees Celsius or more) started.2 Patients who are pregnant or may be pregnant3 Patients with severe hepatic or renal impairment4 Others

Trial Details

Identifiers

Identifier Owner
JapicCTI205238 Japan Pharmaceutical Information Center - Clinical Trials Information

Organisations

  • Sponsors FUJIFILM Toyama Chemical
  • Affiliations FUJIFILM Toyama Chemical

Trial Dates

  • Initiation Dates

    Planned : 31 Mar 2020

    Actual : 31 Mar 2020

  • End Dates

    Planned : 30 Jun 2020

    Actual : 14 Oct 2020

Other Details

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

Interventions

Drugs Route Formulation
FavipiravirPrimary Drug Oral Tablet

Intervention Name: Favipiravir (T-705)

INN of investigational material: Favipiravir
Investigational material:medicine:therapeutic category code: 625 / anti-virus agents
Dosage and administration for investigational material: Oral Multiple Dose

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 [3] [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 Centres

Centres

Download Data (CSV)
Centre Name Location Trial Centre Country
FUJIFILM Toyama Chemical Co., Ltd.
department name for contact: Development Coordination Department
e-mail address: https://www.fujifilm.co.jp/form/fftc/ja/general/input.php?id=FFTCClinicalEn
show details
-
-

+ Lead Centre

Trial History

Event Date Event Type Comment
04 Aug 2022 Other trial event Last checked against JapicCTI record. Updated 04 Aug 2022
29 Dec 2021 Other trial event New source identified and integrated Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI205238) Updated 29 Dec 2021
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. Japan Pharmaceutical Information Center - Clinical Trials Information. Trial-Reg 2016;.

    Available from: URL: http://www.clinicaltrials.jp/user/cteSearch_e.jsp

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

    Media Release

  4. 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

  5. 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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