Influenza, HumanPhase 2NCT03394209
A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza
A Phase 2 study testing Favipiravir and Oseltamivir 75Mg Capsule in people with Influenza, Human and Critical Illness, run by Capital Medical University at 1 site in China.
Trial summary
Title: An adaptive study of the pharmacokinetics of favipiravir in patients with severe influenza Study Design: An open label, single group assignment, adaptive study to evaluate the pharmacokinetics of favipiravir in adult patients with severe influenza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Human, Critical Illness, Influenza
- What is being tested?
- Favipiravir and Oseltamivir 75Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2018to 27 Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized males or females with a positive PCR test for influenza virus infection
- Adults aged ≥18years
- PaO2/FiO2≤300mmHg or on mechanical ventilation
- < 10 days since symptom onset
- Negative pregnancy testing for childbearing age females (under 60 years)
- Willingness to use contraception for 7 days after end of treatment
Show all 13Show fewer
- Informed consent
- In addition, male subjects must:
- Agree not to donate sperm during the study and for 7 days following the last dose of study drug, and
- Agree to adhere strictly to one of the following contraceptive measures from the Screening Visit until 7 days after the last dose of study drug:
- abstain from sexual intercourse or ii. have a female partner using effective means of birth control as noted below or iii. use a condom with spermicide or a second barrier method by female partner.
- Female subjects
- Of child-bearing potential must agree to adhere strictly to one of the following approved contraceptive measures during the study and for 7 days after the last dose of study drug: i. abstain from sexual intercourse or ii. have a male partner incapable of fathering a child (eg, had a vasectomy at least 6 months with history of negative semen analysis prior Screening or iii. use of one of the following methods, in combination with condom and spermicide use by a male partner: nonhormonal intrauterine device (IUD); diaphragm; or hormonal contraceptives including oral contraceptives, injectable subdermal implants, hormonal IUD, or vaginal ring b. Be unable to bear children defined as one of the following: i. absence of a menstrual period for ≥12 consecutive months with FSH confirmation, ii. be 60 years of age or greater, iii. had surgical removal of uterus or removal of both ovaries, or iv. had undergone tubal ligation >6 weeks prior to Day 1 dosing
Who cannot join
- Any condition that does not allow for safely following the protocol
- Patient refusal to accept invasive organ support treatment if needed
- Pregnant or breastfeeding
- Any condition resulted to reception of renal replacement therapy
- AST > 5 times upper of limit or Child Pugh score ≥ C
- Serum uric acid level > 3 times upper level of normal (430 ummol/L) associated with symptoms of gout
Show all 10Show fewer
- Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
- Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
- Physician makes a decision that trial involvement is not in patients' best interest.
- Currently or have been involved in another anti-influenza treatment trial in the last 28 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Adaptive Study of the Pharmacokinetics of Favipiravir in Patients With Severe
Title: An adaptive study of the pharmacokinetics of favipiravir in patients with severe influenza Study Design: An open label, single group assignment, adaptive study to evaluate the pharmacokinetics of favipiravir in adult patients with severe influenza.
In the first stage, participants will receive favipiravir 1600mg BID on day 1, followed by favipiravir 600mg BID for 9 days.
Read more
If the proportion of patients with a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose is less than 80% then a second patient cohort will be recruited and will receive favipiravir 1800mg BID on day 1, followed by favipiravir 800mg BID for 9 days.
Intervention: The 1st stage: 1600mg BID on day 1, followed with 600mg BID for 9 days. Sample size: 15 The 2nd stage: 1800mg BID on day 1, followed with 800mg BID for 9 days. Sample size: 15 Population: Males and females aged 18 years or older admitted to hospital with a positive PCR test for influenza and a PaO2/FiO2≤300mmHg or/and on mechanical ventilation for severe lung infection on admission.
Sample size 15 or 30 severe influenza patients Research hypothesis The administration of oral favipiravir at either 1600mg/600mg BID or 1800/800mg BID will result in ≥ 80% patients achieving a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose.
Phase: Phase 2a, PK, safety and feasibility study. Description of Study Agent: Favipiravir (T-705) a viral RNA-dependent RNA polymerase inhibitor.
Study Duration: 1 year Participant Duration: 38 days
- Conditions
- Influenza, Human, Critical Illness, Influenza
- Being tested
- Favipiravir, Oseltamivir 75Mg Capsule
- Keywords
- Favipiravir, Influenza, Human, Critical Illness, Pharmacokinetics
- Medical subject headings
- Influenza, Human, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called T-705
In first step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1600 mg twice daily. Starting from the second day, the dosage is 600 mg twice daily.
In second step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1800 mg twice daily. Starting from the second day, the dosage is 800 mg twice daily.
Oseltamivir 75Mg CapsuleDrug
oseltamivir will be administered at 75mg twice daily orally for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir+oseltamivir | Experimental | Favipiravir+oseltamivir will be given twice daily for a 10-day period. Receives: Drug: Favipiravir; Drug: Oseltamivir 75Mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with minimum plasma of Favipiravir trough concentration above the MEC (20μg/ml) at all measured time points after the second dose.
Measured: 10 days during the intervention period
Secondary outcomes (13)
Maximum plasma concentration observed over the treatment period (Cmax )
Measured: 10 days during the intervention period
Minimum plasma concentration observed over the treatment period (Cmin)
Measured: 10 days during the intervention period
Average pre-dose plasma concentration (Trough)
Measured: 10 days during the intervention period
Proportion of patients whose favipiravir plasma concentration at least one time exceeds MEC in study days
Measured: 10 days during the intervention period
The proportion of patients falling into each category of a five-point ordinal scale on day 10 and day 28 after starting favipiravir
The category of a five-point ordinal scale: death; hospitalised on ECMO and/or mechanical ventilation; hospitalised on supplemental oxygenation; hospitalised not on supplemental oxygenation; discharged.
Measured: 28 days from starting intervention
Duration (days) of mechanical ventilation
Measured: from reception of mechanical ventilation to ventilator weening, an average of 10 days
Duration (days) of extracorporeal membrane oxygenation
Measured: from starting ECMO to weening, an average of 9 days
Duration (days) of supplemental oxygenation
Measured: Duration (days) of hospitalization with oxygen therapy，an average of 13 days
Duration (days) of hospitalization
Measured: Days from admission to discharge，an average of 19 days
The proportion of patients with a negative RT-PCR for influenza from upper and/or lower respiratory tract samples on day 10 after starting treatment
Measured: Duration of viral shedding,an average of 15 days
The time (days) to negative RT-PCR for influenza from upper and/or lower respiratory tract samples (capped at day 10)
Measured: Duration of viral shedding,an average of 15 days
The proportion of patients with drug related adverse events
Measured: 38 days from starting intervention
The proportion of patients with genetic and phenotypic markers of resistance to favipiravir and/or oseltamivir
Measured: Days from admission to discharge，an average of 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start6 Feb 2018
- Primary completion20 Feb 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a adaptive study, which include two steps. 1st step: 1600mg BID on day 1, followed by 600mg BID for 9 days. Sample size: 15 PK analysis: If the proportion of patients with a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose is greater than or equal to 80% then the dose is considered adequate and the study will be completed. If not, then a second patient cohort will be recruited and will receive favipiravir 1800mg BID on day 1, followed by favipiravir 800mg BID for 9 days. Sample size: 15
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Institute of Pharmacology and Toxicology, University of Oxford, Centers for Disease Control and Prevention, China
- Responsible party
- Principal investigator, Bin Cao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394209
- Sponsor's protocol ID
- FAVI-PK-2017001
- Status last verified
- May 2019
- First submitted
- 25 Dec 2017
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao HN, Lu HZ, Cao B, Du B, Shang H, Gan JH, Lu SH, Yang YD, Fang Q, Shen YZ, Xi XM, Gu Q, Zhou XM, Qu HP, Yan Z, Li FM, Zhao W, Gao ZC, Wang GF, Ruan LX, Wang WH, Ye J, Cao HF, Li XW, Zhang WH, Fang XC, He J, Liang WF, Xie J, Zeng M, Wu XZ, Li J, Xia Q, Jin ZC, Chen Q, Tang C, Zhang ZY, Hou BM, Feng ZX, Sheng JF, Zhong NS, Li LJ. Clinical findings in 111 cases of influenza A (H7N9) virus infection. N Engl J Med. 2013 Jun 13;368(24):2277-85. doi: 10.1056/NEJMoa1305584. Epub 2013 May 22.
PubMed 23697469Zheng S, Tang L, Gao H, Wang Y, Yu F, Cui D, Xie G, Yang X, Zhang W, Ye X, Zhang Z, Wang X, Yu L, Zhang Y, Yang S, Liang W, Chen Y, Li L. Benefit of Early Initiation of Neuraminidase Inhibitor Treatment to Hospitalized Patients With Avian Influenza A(H7N9) Virus. Clin Infect Dis. 2018 Mar 19;66(7):1054-1060. doi: 10.1093/cid/cix930.
PubMed 29077848Li H, Yang SG, Gu L, Zhang Y, Yan XX, Liang ZA, Zhang W, Jia HY, Chen W, Liu M, Yu KJ, Xue CX, Hu K, Zou Q, Li LJ, Cao B, Wang C; National Influenza A(H1N1)pdm09 Clinical Investigation Group of China. Effect of low-to-moderate-dose corticosteroids on mortality of hospitalized adolescents and adults with influenza A(H1N1)pdm09 viral pneumonia. Influenza Other Respir Viruses. 2017 Jul;11(4):345-354. doi: 10.1111/irv.12456. Epub 2017 Jun 9.
PubMed 28464462Wang X, Jiang H, Wu P, Uyeki TM, Feng L, Lai S, Wang L, Huo X, Xu K, Chen E, Wang X, He J, Kang M, Zhang R, Zhang J, Wu J, Hu S, Zhang H, Liu X, Fu W, Ou J, Wu S, Qin Y, Zhang Z, Shi Y, Zhang J, Artois J, Fang VJ, Zhu H, Guan Y, Gilbert M, Horby PW, Leung GM, Gao GF, Cowling BJ, Yu H. Epidemiology of avian influenza A H7N9 virus in human beings across five epidemics in mainland China, 2013-17: an epidemiological study of laboratory-confirmed case series. Lancet Infect Dis. 2017 Aug;17(8):822-832. doi: 10.1016/S1473-3099(17)30323-7. Epub 2017 Jun 2.
PubMed 28583578Dunning J, Baillie JK, Cao B, Hayden FG; International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Antiviral combinations for severe influenza. Lancet Infect Dis. 2014 Dec;14(12):1259-70. doi: 10.1016/S1473-3099(14)70821-7. Epub 2014 Sep 8.
PubMed 25213733Kumar A. Early versus late oseltamivir treatment in severely ill patients with 2009 pandemic influenza A (H1N1): speed is life. J Antimicrob Chemother. 2011 May;66(5):959-63. doi: 10.1093/jac/dkr090. Epub 2011 Mar 15.
PubMed 21406435Kile JC, Ren R, Liu L, Greene CM, Roguski K, Iuliano AD, Jang Y, Jones J, Thor S, Song Y, Zhou S, Trock SC, Dugan V, Wentworth DE, Levine MZ, Uyeki TM, Katz JM, Jernigan DB, Olsen SJ, Fry AM, Azziz-Baumgartner E, Davis CT. Update: Increase in Human Infections with Novel Asian Lineage Avian Influenza A(H7N9) Viruses During the Fifth Epidemic - China, October 1, 2016-August 7, 2017. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):928-932. doi: 10.15585/mmwr.mm6635a2.
PubMed 28880856
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Study of the Pharmacokinetics of Favipiravir in Patients With Severe
- ClinicalTrials.gov ID
- NCT03394209
- Acronym / sponsor ID
- FAVI-PK-2017001
- Conditions
- Influenza, Human, Critical Illness, Influenza
- Keywords
- Favipiravir, Influenza, Human, Critical Illness, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Institute of Pharmacology and Toxicology, University of Oxford, Centers for Disease Control and Prevention, China
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: An adaptive study of the pharmacokinetics of favipiravir in patients with severe influenza Study Design: An open label, single group assignment, adaptive study to evaluate the pharmacokinetics of favipiravir in adult patients with severe influenza.
In the first stage, participants will receive favipiravir 1600mg BID on day 1, followed by favipiravir 600mg BID for 9 days.
If the proportion of patients with a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose is less than 80% then a second patient cohort will be recruited and will receive favipiravir 1800mg BID on day 1, followed by favipiravir 800mg BID for 9 days.
Intervention: The 1st stage: 1600mg BID on day 1, followed with 600mg BID for 9 days. Sample size: 15 The 2nd stage: 1800mg BID on day 1, followed with 800mg BID for 9 days. Sample size: 15 Population: Males and females aged 18 years or older admitted to hospital with a positive PCR test for influenza and a PaO2/FiO2≤300mmHg or/and on mechanical ventilation for severe lung infection on admission.
Sample size 15 or 30 severe influenza patients Research hypothesis The administration of oral favipiravir at either 1600mg/600mg BID or 1800/800mg BID will result in ≥ 80% patients achieving a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose.
Phase: Phase 2a, PK, safety and feasibility study. Description of Study Agent: Favipiravir (T-705) a viral RNA-dependent RNA polymerase inhibitor.
Study Duration: 1 year Participant Duration: 38 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a adaptive study, which include two steps. 1st step: 1600mg BID on day 1, followed by 600mg BID for 9 days. Sample size: 15 PK analysis: If the proportion of patients with a minimum observed plasma trough concentration above the MEC (20μg/ml) at all measured time points after the second dose is greater than or equal to 80% then the dose is considered adequate and the study will be completed. If not, then a second patient cohort will be recruited and will receive favipiravir 1800mg BID on day 1, followed by favipiravir 800mg BID for 9 days. Sample size: 15
| Arm | Type | Receives |
|---|---|---|
| Favipiravir+oseltamivir | Experimental | Drug: Favipiravir, Drug: Oseltamivir 75Mg CapsuleFavipiravir+oseltamivir will be given twice daily for a 10-day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hospitalized males or females with a positive PCR test for influenza virus infection
- Adults aged ≥18years
- PaO2/FiO2≤300mmHg or on mechanical ventilation
- < 10 days since symptom onset
- Negative pregnancy testing for childbearing age females (under 60 years)
Key exclusion criteria (10 listed)
- Any condition that does not allow for safely following the protocol
- Patient refusal to accept invasive organ support treatment if needed
- Pregnant or breastfeeding
- Any condition resulted to reception of renal replacement therapy
- AST > 5 times upper of limit or Child Pugh score ≥ C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FavipiravirAlso: T-705In first step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1600 mg twice daily. Starting from the second day, the dosage is 600 mg twice daily. In second step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1800 mg twice daily. Starting from the second day, the dosage is 800 mg twice daily. | Drug | Favipiravir+oseltamivir |
| Oseltamivir 75Mg Capsuleoseltamivir will be administered at 75mg twice daily orally for 10 days | Drug | Favipiravir+oseltamivir |
Primary outcome
Proportion of patients with minimum plasma of Favipiravir trough concentration above the MEC (20μg/ml) at all measured time points after the second dose.
Time frame: 10 days during the intervention period
13 secondary outcomes
Maximum plasma concentration observed over the treatment period (Cmax )
Time frame: 10 days during the intervention period
Minimum plasma concentration observed over the treatment period (Cmin)
Time frame: 10 days during the intervention period
Average pre-dose plasma concentration (Trough)
Time frame: 10 days during the intervention period
Proportion of patients whose favipiravir plasma concentration at least one time exceeds MEC in study days
Time frame: 10 days during the intervention period
The proportion of patients falling into each category of a five-point ordinal scale on day 10 and day 28 after starting favipiravir
Time frame: 28 days from starting intervention
Duration (days) of mechanical ventilation
Time frame: from reception of mechanical ventilation to ventilator weening, an average of 10 days
Duration (days) of extracorporeal membrane oxygenation
Time frame: from starting ECMO to weening, an average of 9 days
Duration (days) of supplemental oxygenation
Time frame: Duration (days) of hospitalization with oxygen therapy，an average of 13 days
Duration (days) of hospitalization
Time frame: Days from admission to discharge，an average of 19 days
The proportion of patients with a negative RT-PCR for influenza from upper and/or lower respiratory tract samples on day 10 after starting treatment
Time frame: Duration of viral shedding,an average of 15 days
The time (days) to negative RT-PCR for influenza from upper and/or lower respiratory tract samples (capped at day 10)
Time frame: Duration of viral shedding,an average of 15 days
The proportion of patients with drug related adverse events
Time frame: 38 days from starting intervention
The proportion of patients with genetic and phenotypic markers of resistance to favipiravir and/or oseltamivir
Time frame: Days from admission to discharge，an average of 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publication: PubMed 23697469Gao HN, Lu HZ, Cao B, Du B, Shang H, Gan JH, Lu SH, Yang YD, Fang Q, Shen YZ, Xi XM, Gu Q, Zhou XM, Qu HP, Yan Z, Li FM, Zhao W, Gao ZC, Wang GF, Ruan LX, Wang WH, Ye J, Cao HF, Li XW, Zhang WH, Fang XC, He J, Liang WF, Xie J, Zeng M, Wu XZ, Li J, Xia Q, Jin ZC, Chen Q, Tang C, Zhang ZY, Hou BM, Feng ZX, Sheng JF, Zhong NS, Li LJ. Clinical findings in 111 cases of influenza A (H7N9) virus infection. N Engl J Med. 2013 Jun 13;368(24):2277-85. doi: 10.1056/NEJMoa1305584. Epub 2013 May 22.
- Results publication: PubMed 29077848Zheng S, Tang L, Gao H, Wang Y, Yu F, Cui D, Xie G, Yang X, Zhang W, Ye X, Zhang Z, Wang X, Yu L, Zhang Y, Yang S, Liang W, Chen Y, Li L. Benefit of Early Initiation of Neuraminidase Inhibitor Treatment to Hospitalized Patients With Avian Influenza A(H7N9) Virus. Clin Infect Dis. 2018 Mar 19;66(7):1054-1060. doi: 10.1093/cid/cix930.
- Results publication: PubMed 28464462Li H, Yang SG, Gu L, Zhang Y, Yan XX, Liang ZA, Zhang W, Jia HY, Chen W, Liu M, Yu KJ, Xue CX, Hu K, Zou Q, Li LJ, Cao B, Wang C; National Influenza A(H1N1)pdm09 Clinical Investigation Group of China. Effect of low-to-moderate-dose corticosteroids on mortality of hospitalized adolescents and adults with influenza A(H1N1)pdm09 viral pneumonia. Influenza Other Respir Viruses. 2017 Jul;11(4):345-354. doi: 10.1111/irv.12456. Epub 2017 Jun 9.
- Results publication: PubMed 28583578Wang X, Jiang H, Wu P, Uyeki TM, Feng L, Lai S, Wang L, Huo X, Xu K, Chen E, Wang X, He J, Kang M, Zhang R, Zhang J, Wu J, Hu S, Zhang H, Liu X, Fu W, Ou J, Wu S, Qin Y, Zhang Z, Shi Y, Zhang J, Artois J, Fang VJ, Zhu H, Guan Y, Gilbert M, Horby PW, Leung GM, Gao GF, Cowling BJ, Yu H. Epidemiology of avian influenza A H7N9 virus in human beings across five epidemics in mainland China, 2013-17: an epidemiological study of laboratory-confirmed case series. Lancet Infect Dis. 2017 Aug;17(8):822-832. doi: 10.1016/S1473-3099(17)30323-7. Epub 2017 Jun 2.
- Results publication: PubMed 25213733Dunning J, Baillie JK, Cao B, Hayden FG; International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Antiviral combinations for severe influenza. Lancet Infect Dis. 2014 Dec;14(12):1259-70. doi: 10.1016/S1473-3099(14)70821-7. Epub 2014 Sep 8.
- Results publication: PubMed 21406435Kumar A. Early versus late oseltamivir treatment in severely ill patients with 2009 pandemic influenza A (H1N1): speed is life. J Antimicrob Chemother. 2011 May;66(5):959-63. doi: 10.1093/jac/dkr090. Epub 2011 Mar 15.
- Results publication: PubMed 28880856Kile JC, Ren R, Liu L, Greene CM, Roguski K, Iuliano AD, Jang Y, Jones J, Thor S, Song Y, Zhou S, Trock SC, Dugan V, Wentworth DE, Levine MZ, Uyeki TM, Katz JM, Jernigan DB, Olsen SJ, Fry AM, Azziz-Baumgartner E, Davis CT. Update: Increase in Human Infections with Novel Asian Lineage Avian Influenza A(H7N9) Viruses During the Fifth Epidemic - China, October 1, 2016-August 7, 2017. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):928-932. doi: 10.15585/mmwr.mm6635a2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Favipiravir and Oseltamivir 75Mg Capsule in people with Influenza, Human and Critical Illness, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with minimum plasma of Favipiravir trough concentration above the MEC (20μg/ml) at all measured time points after the second dose. (time frame: 10 days during the intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394209, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.