A Phase 2 interventional study of Favipiravir and Oseltamivir 75Mg Capsule in Influenza, Human, Critical Illness and Influenza, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Capital Medical University · Phase 2, Interventional, and Treatment
Among 12 studies in Influenza, Human by Capital Medical University — 7 open to participants now, 7 under way, 3 of them phase 3. Influenza, Human · Capital Medical University.
Among the 12 studies in Influenza, Human by Capital Medical University, this one is the 11th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 2, and was the 3rd registered.
2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.
Browse Influenza, Human studies →7 of the 12 studies in Influenza, Human by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:
Capital Medical University · Sites in China
Ages 12+
Capital Medical University · Sites in China
Ages 18–65
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 18–64
Capital Medical University · Sites in China
Ages 12–65
By country, each count listing its studies:
Of the 120 Influenza, Human studies recruiting now, 64 (53%) set no upper age limit and 46 (38%) stop at 75 or younger; 33 take children under 18; 66 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 4 · Phase 4 2
First in 2009; this study’s year is marked. 1 started in 2018.
This study's enrollment of 34 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 384 across the 11 interventional studies, 1,000 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Capital Medical University is the lead sponsor of 296 studies on the registry; 90 are open to participants now.
2 of the studies in Influenza, Human by Capital Medical University that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07236814Phase 3Capital Medical UniversitySuraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting | 2027-03-01 |
| NCT07893847Phase 3Capital Medical UniversityEvaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza | 2027-03-30 |
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Among the 12 studies in Influenza, Human by Capital Medical University, from their registry updates:
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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
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.
In addition, male subjects must:
i. 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
a. Of 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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Favipiravir+oseltamivir will be given twice daily for a 10-day period.
Drug: Favipiravir · Drug: Oseltamivir 75Mg Capsule
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.
Also known as: T-705
oseltamivir will be administered at 75mg twice daily orally for 10 days
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
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
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.
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
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Feb 2019, 12 months.
Of 36 non-industry phase 2 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 12 months is below that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Favipiravir