Clinical Trial of Favipiravir Treatment of Patients With COVID-19

NCT04600999 | Completed Phase 3 DMC

• 1 other identifier: HUN-AVI-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

To verify that the efficacy of favipiravir exceeds that of the actual supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild pneumonia, using the time required to improve clinical symptoms as the primary endpoint.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (4)

• Time to improvement in body temperature

  9 month

• Time to improvement in SpO2

  9 month

• Time to improvement in chest imaging findings

  9 month

• Time to improvement in negative SARS-CoV-2

  9 month

Secondary Outcomes (11)

• (1) Changes in patient status on a 5-point scale

  9 month

• (2) Changes in the level of SARS-CoV-2 viral genome

  9 month

• (3) SARS-CoV-2 virus genome clearance rate

  9 month

• (4) Duration of pyrexia

  9 month

• (5) Changes in clinical symptoms

  9 month

Study Arms (2)

Group Avigan

EXPERIMENTAL

Favipiravir from Day1 + Supportive care (symptomatic therapy) a regimen of 3600 mg (1800 mg twice a day orally) loading dose on Day1 followed by 1600 mg maintenance dose (800 mg twice a day orally) on Day2 to Day14.

Drug: Favipiravir

Group Control

NO INTERVENTION

Supportive care (symptomatic therapy)

Interventions

Favipiravir DRUG

Name: AVIGAN Generic name: Favipiravir Content: T-705a tablets \[200\]

Group Avigan

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 74 years (at the time of informed consent)
• Male or female
• Patients who meet all of the following three criteria at the time of enrolment:
• SARS-CoV-2-positive patients as measured by rtPCR by nasopharyngeal sampling
• Moderate patients with radiological evidence of pneumonia in the lung at the time of enrolment (RTG, CT, or UH), clearly described by the radiologist following the imaging examination. (The diagnosis of the finding should clearly include the presence of pneumonia to any extent, localization, and extent)
• Body temperature 37,5°C or more
• Patient requires hospitalization during the treatment period (obligation to stay in the hospital for whole treatment period, 14 days)
• For premenopausal females, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug
• Signed informed consent by the patient or by the legal representative -

You may not qualify if:

• Body temperature of 37.5 °C or higher for more than 10 days after the onset of elevated body temperature
• Patients with SpO2 less than 95%
• Patient requires supportive oxygen therapy
• Patients who show increased procalcitonin levels before the start of the study drug administration and are suspected to have concurrent bacterial infection
• Patients with proven concomitant systematic fungal infection prior to initiation of study drug.
• Patients with concurrent congestive heart failure (NYHA III-IV)
• Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
• Patient with renal impairment requiring dialysis.
• Patients with disturbed consciousness such as disturbed orientation.
• Pregnant or possibly pregnant patients.
• Female patients who are woman of childbearing potential and unable to consent to the use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation
• Male patients whose are unable to consent to the use of the barrier method of contraception (condom) from the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm from the start up until 90 days after the end of favipiravir administration.
• Female patients who intend to breastfeed from the start of favipiravir administration until 14 days after discontinuation of favipiravir administration
• Patients with herditary xanthinuria
• Patients who have hyperuricemia (\> 1 mg/dL) or xanthine urinary calculi

Sponsors & Collaborators

• University of Pecs: lead
• HECRIN Consortium: collaborator
• Hungarian Ministry of Innovation and Technology: collaborator

Study Sites (5)

Department of Pulmonology Semmelweis University

Budapest, 1083, Hungary

Location

National Korányi Institute for Pulmonology

Budapest, 1121, Hungary

Location

Institute of Infectology, University of Debrecen

Debrecen, 4031, Hungary

Location

1st Department of Medicine, University of Pécs

Pécs, 7624, Hungary

Location

First Department of Internal Medicine, University of Szeged

Szeged, 6720, Hungary

Location

Related Publications (5)

• Gowen BB, Wong MH, Jung KH, Sanders AB, Mendenhall M, Bailey KW, Furuta Y, Sidwell RW. In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections. Antimicrob Agents Chemother. 2007 Sep;51(9):3168-76. doi: 10.1128/AAC.00356-07. Epub 2007 Jul 2.

  PMID: 17606691 BACKGROUND

• Mendenhall M, Russell A, Smee DF, Hall JO, Skirpstunas R, Furuta Y, Gowen BB. Effective oral favipiravir (T-705) therapy initiated after the onset of clinical disease in a model of arenavirus hemorrhagic Fever. PLoS Negl Trop Dis. 2011 Oct;5(10):e1342. doi: 10.1371/journal.pntd.0001342. Epub 2011 Oct 11.

  PMID: 22022624 BACKGROUND

• Oestereich L, Ludtke A, Wurr S, Rieger T, Munoz-Fontela C, Gunther S. Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model. Antiviral Res. 2014 May;105:17-21. doi: 10.1016/j.antiviral.2014.02.014. Epub 2014 Feb 26.

  PMID: 24583123 BACKGROUND

• Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.

  PMID: 32020029 BACKGROUND

• Bai CQ, Mu JS, Kargbo D, Song YB, Niu WK, Nie WM, Kanu A, Liu WW, Wang YP, Dafae F, Yan T, Hu Y, Deng YQ, Lu HJ, Yang F, Zhang XG, Sun Y, Cao YX, Su HX, Sun Y, Liu WS, Wang CY, Qian J, Liu L, Wang H, Tong YG, Liu ZY, Chen YS, Wang HQ, Kargbo B, Gao GF, Jiang JF. Clinical and Virological Characteristics of Ebola Virus Disease Patients Treated With Favipiravir (T-705)-Sierra Leone, 2014. Clin Infect Dis. 2016 Nov 15;63(10):1288-1294. doi: 10.1093/cid/ciw571. Epub 2016 Aug 23.

  PMID: 27553371 BACKGROUND

Related Links

• Report of Clinical Course of 4 Patients with Coronavirus Disease 2019 (COVID-19) Who Required Oxygen Administration

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• István Várkonyi

  Institute of Infectology University of Debrecen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 23, 2020
• Study Start: October 7, 2020
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5)