- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600999
Clinical Trial of Favipiravir Treatment of Patients With COVID-19
October 30, 2022 updated by: University of Pecs
An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients With Mild Pneumonia - An Open-label Randomized Controlled Study -
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Budapest, Hungary, 1083
- Department of Pulmonology Semmelweis University
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Budapest, Hungary, 1121
- National Koranyi Institute for Pulmonology
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Debrecen, Hungary, 4031
- Institute of Infectology, University of Debrecen
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Pécs, Hungary, 7624
- 1st Department of Medicine, University of Pécs
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Szeged, Hungary, 6720
- First Department of Internal Medicine, University of Szeged
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 -
Exclusion Criteria:
- 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
- Patients with a history of gout or on treatment for gout or hyperuricemia
- Patients receiving immunosuppressants
- Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 9 days after fever onset (37.5°C or more)
- Patients in whom this episode of infection is a recurrence or a reinfection with the SARS-CoV-2 infection
- Patients who have previously been treated with favipiravir (T-705a)
Other patients judged ineligible by the investigator, sub-investigator, or assigned physician.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Avigan
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.
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Name: AVIGAN Generic name: Favipiravir Content: T-705a tablets [200]
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No Intervention: Group Control
Supportive care (symptomatic therapy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to improvement in body temperature
Time Frame: 9 month
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9 month
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Time to improvement in SpO2
Time Frame: 9 month
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9 month
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Time to improvement in chest imaging findings
Time Frame: 9 month
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9 month
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Time to improvement in negative SARS-CoV-2
Time Frame: 9 month
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9 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(1) Changes in patient status on a 5-point scale
Time Frame: 9 month
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Name of the scale is: Patient Status Score.
1:A condition in which the patient can be discharged; 5:A condition requiring ECMO or invasive oxygen therapy and ICU management
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9 month
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(2) Changes in the level of SARS-CoV-2 viral genome
Time Frame: 9 month
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9 month
|
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(3) SARS-CoV-2 virus genome clearance rate
Time Frame: 9 month
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9 month
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(4) Duration of pyrexia
Time Frame: 9 month
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9 month
|
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(5) Changes in clinical symptoms
Time Frame: 9 month
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Changes in clinical symptoms, including: Patient's condition; Coughing, Sore throat, Headache, Muscle or joint pain, Nasal congestion or Nasal discharge, Chills or sweating, Malaise or fatigue, Chest pain, dehydration, cyanosis, pleural effusion, Thoracic rales, Conscious state.
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9 month
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(6) Changes in NEWS (National Early Warning Score)
Time Frame: 9 month
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Changes in NEWS (unabbreviated scale title: National Early Warning Score).
Calculate the total value from the clinical symptoms and findings (consciousness) and vital signs (SpO2, body temperature, blood pressure, pulse rate, respiratory rate).
0 is normal
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9 month
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(7) Changes in chest imaging findings on Days 4,7,10,13,16,19,22,25,28.
Time Frame: Changes in chest imaging findings will be collected and checked on Days 4,7,10,13,16,19,22,25,28, the data will be analyzied at 9. month.
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Changes in chest imaging findings will be collected and checked on Days 4,7,10,13,16,19,22,25,28, the data will be analyzied at 9. month.
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(8) Percentage of patients requiring adjuvant oxygen therapy
Time Frame: 9 month
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9 month
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(8) Adjuvant oxygen therapy average duration
Time Frame: 9 month
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9 month
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(9) Percentage of patients requiring mechanical ventilation therapy
Time Frame: 9 month
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9 month
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(9)Adjuvant oxygen therapy average durationduration
Time Frame: 9 month
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9 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: István Várkonyi, Institute of Infectology University of Debrecen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2020
Primary Completion (Actual)
December 28, 2020
Study Completion (Actual)
December 28, 2020
Study Registration Dates
First Submitted
October 8, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 30, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUN-AVI-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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