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CompletedNCT04600999Updated Nov 1, 2022

Clinical Trial of Favipiravir Treatment of Patients With COVID-19

A Phase 3 interventional study of Favipiravir in SARS-CoV-2 Infection, sponsored by University of Pecs. Completed at 5 sites in Hungary. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by University of Pecs · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • SARS-CoV-2 Infection

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

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Lead sponsor

University of Pecs is the lead sponsor of 105 studies on the registry; 25 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 74 years (at the time of informed consent)
  2. Male or female

  3. Patients who meet all of the following three criteria at the time of enrolment:

    1. SARS-CoV-2-positive patients as measured by rtPCR by nasopharyngeal sampling
    2. 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)
    3. Body temperature 37,5°C or more
    4. Patient requires hospitalization during the treatment period (obligation to stay in the hospital for whole treatment period, 14 days)
  4. For premenopausal females, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug
  5. Signed informed consent by the patient or by the legal representative -

Exclusion criteria

Exclusion Criteria:

  1. Body temperature of 37.5 °C or higher for more than 10 days after the onset of elevated body temperature
  2. Patients with SpO2 less than 95%
  3. Patient requires supportive oxygen therapy
  4. Patients who show increased procalcitonin levels before the start of the study drug administration and are suspected to have concurrent bacterial infection
  5. Patients with proven concomitant systematic fungal infection prior to initiation of study drug.
  6. Patients with concurrent congestive heart failure (NYHA III-IV)
  7. Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
  8. Patient with renal impairment requiring dialysis.
  9. Patients with disturbed consciousness such as disturbed orientation.
  10. Pregnant or possibly pregnant patients.
  11. 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
  12. 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.
  13. Female patients who intend to breastfeed from the start of favipiravir administration until 14 days after discontinuation of favipiravir administration
  14. Patients with herditary xanthinuria
  15. Patients who have hyperuricemia (> 1 mg/dL) or xanthine urinary calculi
  16. Patients with a history of gout or on treatment for gout or hyperuricemia
  17. Patients receiving immunosuppressants
  18. 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)
  19. Patients in whom this episode of infection is a recurrence or a reinfection with the SARS-CoV-2 infection
  20. Patients who have previously been treated with favipiravir (T-705a)

  21. Other patients judged ineligible by the investigator, sub-investigator, or assigned physician.

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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.

    Drug: Favipiravir

  • No intervention
    Group Control

    Supportive care (symptomatic therapy)

Interventions

  • DrugFavipiravir

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

06

What researchers measure

Primary outcomes

  1. Time to improvement in body temperature

    Time frame: 9 month

  2. Time to improvement in SpO2

    Time frame: 9 month

  3. Time to improvement in chest imaging findings

    Time frame: 9 month

  4. Time to improvement in negative SARS-CoV-2

    Time frame: 9 month

Secondary outcomes

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

    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

    Time frame: 9 month

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

    Time frame: 9 month

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

    Time frame: 9 month

  4. (4) Duration of pyrexia

    Time frame: 9 month

  5. (5) Changes in clinical symptoms

    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.

    Time frame: 9 month

  6. (6) Changes in NEWS (National Early Warning Score)

    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

    Time frame: 9 month

  7. (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.

  8. (8) Percentage of patients requiring adjuvant oxygen therapy

    Time frame: 9 month

  9. (8) Adjuvant oxygen therapy average duration

    Time frame: 9 month

  10. (9) Percentage of patients requiring mechanical ventilation therapy

    Time frame: 9 month

  11. (9)Adjuvant oxygen therapy average durationduration

    Time frame: 9 month

07

Study locations

5 sites
  • Department of Pulmonology Semmelweis University
    Budapest, 1083, Hungary
  • National Korányi Institute for Pulmonology
    Budapest, 1121, Hungary
  • Institute of Infectology, University of Debrecen
    Debrecen, 4031, Hungary
  • 1st Department of Medicine, University of Pécs
    Pécs, 7624, Hungary
  • First Department of Internal Medicine, University of Szeged
    Szeged, 6720, Hungary
08

References and documents

Publications

  • 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. PubMed 17606691 ↗
  • 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. PubMed 22022624 ↗
  • 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. PubMed 24583123 ↗
  • 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. PubMed 32020029 ↗
  • 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. PubMed 27553371 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04600999
Lead sponsor
University of Pecs
Collaborators
HECRIN Consortium, Ministry of Innovation and Technology, Hungary
Responsible party
Sponsor
First posted
Oct 23, 2020
Start date
Oct 7, 2020
Primary completion
Dec 28, 2020
Completion
Dec 28, 2020
Last update
Nov 1, 2022

Study contacts

István Várkonyi
principal investigator · Institute of Infectology University of Debrecen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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