Clinical study on safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)
Latest Information Update: 17 Jun 2020
At a glance
- Drugs Favipiravir (Primary) ; Interferon alpha-1b; Lopinavir/ritonavir
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- 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.
Most Recent Events
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 |
Group A:alpha-Interferon atomization;Group B:Lopinavir and Ritonavir + alpha-Interferon atomization;Group C:Favipiravir + alpha-Interferon atomization;
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
-
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 -
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
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Liao Xuejiao
Telephone: +86 755 612223333-1214
show details
392402597@qq.com 9 Bulan Road, Longgang District, Shenzhen, Guangdong, China |
The Third People's Hospital of Shenzhen | China |
|
Liu Yingxia
National Clinical Research Center for Infectious Diseases, The Third People's Hospital of Shenzhen
show details
Study leader's telephone+86 755 61238922 29 Bulan Road, Longgang District, Shenzhen, Guangdong, China yingxialiu@hotmail.com |
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 |
|---|---|---|
| 17 Jun 2020 | Other trial event | Last checked against China Clinical Trials Register record. Updated 17 Jun 2020 |
| 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 |
Table of Contents
References
-
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 -
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 -
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org
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