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Clinical study on safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)

Trial Profile

Clinical study on safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)

Status: Recruiting
Phase of Trial: Phase 0

Latest Information Update: 16 May 2020

At a glance

  • Drugs Favipiravir (Primary) ; Interferon alpha-1b; Lopinavir/ritonavir
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 May 2020 New source identified and integrated (Chinese Clinical Trial Register ChiCTR2000029600).
    • 24 Mar 2020 New trial record
    • 19 Mar 2020 According to an Zhejiang Hisun Pharmaceutical Media Release, preliminary results of this study were released at a press conference held by the Ministry of Science and Technology of the P.R.C.

Trial Overview

Purpose

This pilot, phase 0, before-after controlled study was designed to observe the safety and efficacy of Favipiravir (FPV) versus Lopinavir (LPV)/ritonavir (RTV) for the treatment of 2019-nCoV pneumonia.Patients who had initially been treated with antiviral therapy with LPV/RTV from 24 January to 30 January 2020 were screened, and eligible patients were included in the control arm of the study.From 30 January, patients with laboratory-confirmed COVID-19 were screened, and eligible patients were enrolled for the FPV arm of the study.
This study used quasi-experimental design.
Patients with laboratory-confirmed COVID-19 who received oral FPV (Day 1: 1600 mg twice daily; Days 2–14: 600 mg twice daily) plus interferon (IFN)-a by aerosol inhalation (5 million U twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1–14: 400 mg/100 mg twice daily) plus IFN-a by aerosol inhalation (5 million U twice daily) were included in the control arm.

Primary Endpoints

−Declining speed of Novel Coronavirus by PCR

−Negative Time of Novel Coronavirus by PCR

−Incidentce rate of chest imaging

−Incidence rate of liver enzymes

−Incidence rate of kidney damage

Other Endpoints

−Safety (adverse events and by laboratory tests) [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 90

  • Sex male & female
  • Age Group 16-75 years; adolescent; adult; elderly

Patient Inclusion Criteria

1. 16 to 75 years of age, male or female.
2. Respiratory or blood samples tested positive for novel coronavirus.
3. Within 7 days of onset: Onset is defined as body temperature exceeding 38 degree C (armpit temperature) or at least one 2019-nCoV pneumonia related systemic or respiratory symptom.
4. Willing to take contraception during the study and within 7 days after treatment.
5. No difficulty in swallowing the Pills.
6. Willing to sign informed consent form.

Patient Exclusion Criteria

1. Any situation which the protocol cannot be carried out safely.
2. Patient refuses to receive invasive tracheal support (if needed).
3. Pregnant or lactating women:childbearing age women with positive pregnancy test, breastfeeding, miscarriage or within 2 weeks after delivery.Postmenopausal and hysterectomy women do not need a pregnancy test.
4. Patients with chronic liver and kidney disease and reaching end-stage.
5. Previous history of allergic reactions to Fapiravir or Lopinavir and Ritonavir.
6. Currently or in the past 28 days, participated in another clinical trial against novel coronavirus treatment.
7. After the investigator's judgment, the subjects could not participate the study protocol, follow-up or self-evaluation after enrollment.

Trial Details

Identifiers

Identifier Owner
ChiCTR2000029600 Chinese Clinical Trial Register
2020-002-02 -

Organisations

  • Affiliations Zhejiang Hisun Pharmaceutical

Trial Dates

  • Initiation Dates

    Actual : 30 Jan 2020

  • End Dates

    Planned : 29 Apr 2020

Other Details

  • Design open; prospective
  • Phase of Trial Phase 0
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
FavipiravirPrimary Drug Oral Tablet
Interferon alpha-1b Inhalation Aerosol
Lopinavir/ritonavir Oral Tablet

Patients with laboratory-confirmed COVID-19 who received oral Favipiravir (FPV) (Day 1: 1600 mg twice daily; Days 2–14: 600 mg twice daily) plus interferon (IFN)-a by aerosol inhalation (5 million U twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1–14: 400 mg/100 mg twice daily) plus IFN-a by aerosol inhalation (5 million U twice daily) were included in the control arm.
Both FPV and LPV/RTV were continued until the viral clearance was confirmed or until 14 d had passed.

Group A (alpha-Interferon atomization)

alpha-Interferon atomization (IFN-α1b)
IFN-α1b 60 µg (Beijing Tri-Prime Gene Pharmaceutical Co., 30 μg per ampule) twice daily by aerosol inhalation.

Group B (Lopinavir and Ritonavir + alpha-Interferon atomization)

Lopinavir and Ritonavir (LPV/RTV; AbbVie Inc., 200 mg/50 mg per tablet)
alpha-Interferon atomization (IFN-α1b 60 µg; Beijing Tri-Prime Gene Pharmaceutical Co., 30 μg per ampule) twice daily by aerosol inhalation.
Patients received LPV/RTV (Days 1–14: 400 mg/100 mg twice daily) plus IFN-a by aerosol inhalation (5 million U twice daily).

Group C (Favipiravir + alpha-Interferon atomization)

Favipiravir (FPV; Zhejiang Hisun Pharmaceutical Co., Ltd., 200 mg per tablet)
alpha-Interferon atomization (IFN-α1b 60 µg; Beijing Tri-Prime Gene Pharmaceutical Co., 30 μg per ampule) twice daily by aerosol inhalation.
Patients received oral Favipiravir (FPV; Zhejiang Hisun Pharmaceutical Co., Ltd., 200 mg per tablet) (Day 1: 1600 mg twice daily; Days 2–14: 600 mg twice daily) plus interferon (IFN)-a by aerosol inhalation (5 million U twice daily).

Results

Therapeutic efficacy

In a clinical trial in patients with COVID-2019 infections, significant clinical differences were observed between the 35-patient experimental group treated with favipiravir and the 45-patient control group treated with lopinavir/ritonavir. The medians of the virus clearance time were 4 days (2.5 ~ 9 days) and 11 days (8 ~ 13 days), respectively (P < 0.001); the posttreatment fever-allaying rates within 2 days were 72.41% versus 26.30%; while the chest-imaging improvement rates were 91.43% versus 62.22% [2] .

Adverse events

Clinical:
In a clinical trial in patients with COVID-2019 infections, the rate of adverse reaction in favipiravir-treated patients was 11.43% and in dontrol group treated with lopinavir/ritonavir was 55.56% [2] .

Publications

  1. Qingxian Cai, Minghui Yang, Dongjing Liu, Jun Chen, Dan Shu, Junxia Xia, et al. Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Internet-Doc 2020;.

    Available from: URL: https://www.sciencedirect.com/science/article/pii/S2095809920300631
  2. Zhejiang Hisun Pharmaceutical. Zhejiang Hisun Pharmaceutical Co. Ltd.: Favipiravir Works - Preliminary Clinical Studies Suggest Positive Effects on COVID-19 Patients. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Chenguang Shen 1 - -
Dan Shu 1 - -
Deliang Huang 1 - -
Dongjing Liu 1 - -
Fuxiang Wang 1 - -
Jiaye Liu 1 - -
Jing Zhang 1 - -
Jun Chen 1 - -
Junxia Xia 1 - -
Lei Liu 1 - 1
Li Chen 1 - -
Ling Peng 1 - -
Minghui Yang 1 - -
Qingxian Cai 1 1 -
Qiue Cai 1 - -
Ruiyuan Cao 1 - -
Shurong Zhang 1 - -
Shuyan Chen 1 - -
Wu Zhong 1 - -
Xiaohe Li 1 - -
Xuejiao Liao 1 - -
Yang Yang 1 - -
Yingxia Liu 1 - -
Yuanbo Gu 1 - -
Zhaoqin Wang 1 - -
Zhejiang Hisun Pharmaceutical 1 1 1
Zheng Zhang 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Liao Xuejiao
Telephone: +86 755 612223333-1214
392402597@qq.com
9 Bulan Road, Longgang District, Shenzhen, Guangdong, China
show details
The Third People's Hospital of Shenzhen China
Liu Yingxia
National Clinical Research Center for Infectious Diseases, The Third People's Hospital of Shenzhen
Study leader's telephone+86 755 61238922
29 Bulan Road, Longgang District, Shenzhen, Guangdong, China
yingxialiu@hotmail.com
show details
The Third People's Hospital of Shenzhen China

Centres

Centre Name Location Trial Centre Country
The Third People's Hospital of Shenzhen Shenzhen, Guangdong China

Trial History

Event Date Event Type Comment
16 May 2020 Other trial event New source identified and integrated (Chinese Clinical Trial Register ChiCTR2000029600). Updated 16 May 2020
24 Mar 2020 New trial record New trial record Updated 24 Mar 2020
19 Mar 2020 Interim results According to an Zhejiang Hisun Pharmaceutical Media Release, preliminary results of this study were released at a press conference held by the Ministry of Science and Technology of the P.R.C. Updated 24 Mar 2020
19 Mar 2020 Interim results Preliminary results(n=80) published in the Zhejiang Hisun Pharmaceutical Media Release. Updated 24 Mar 2020
18 Mar 2020 Results Results published in an Engineering Journal. Updated 16 May 2020

References

  1. Qingxian Cai, Minghui Yang, Dongjing Liu, Jun Chen, Dan Shu, Junxia Xia, et al. Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Internet-Doc 2020;.

    Available from: URL: https://www.sciencedirect.com/science/article/pii/S2095809920300631
  2. Zhejiang Hisun Pharmaceutical. Zhejiang Hisun Pharmaceutical Co. Ltd.: Favipiravir Works - Preliminary Clinical Studies Suggest Positive Effects on COVID-19 Patients. Media-Rel 2020;.

    Media Release
  3. Chinese Clinical Trial Register. Trial-Reg 2016;.

    Available from: URL: http://www.chictr.org
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