NCT03394209

A Pharmacokinetics Study of Favipiravir in Patients With Severe Influenza

Completed Phase 2 Last updated 15 May 2019

What this trial tests

Phase 2 trial testing Favipiravir in Influenza, Human in 34 participants. Completed in 27 March 2019.

Timeline

6 February 2018

Primary endpoint
20 February 2019

27 March 2019

Quick facts

Lead sponsor	Capital Medical University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	6 February 2018
Primary completion	20 February 2019
Estimated completion	27 March 2019
Sites	1 location across China

Drugs / interventions tested

• Favipiravir (FAVIPIRAVIR) — full drug profile →
• Oseltamivir 75Mg Capsule

Conditions studied

• Influenza, Human — all drugs for Influenza, Human →
• Critical Illness — all drugs for Critical Illness →
• Influenza — all drugs for Influenza →

Sponsor

Capital Medical University

Who can join

18 and older, any sex, with Influenza, Human or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Influenza virus polymerase inhibitors in clinical development.
   Hayden FG, Shindo N. · · 2019 · cited 149× · PMID 30724789 · DOI 10.1097/qco.0000000000000532
2. Overview of Current Therapeutics and Novel Candidates Against Influenza, Respiratory Syncytial Virus, and Middle East Respiratory Syndrome Coronavirus Infections.
   Behzadi MA, Leyva-Grado VH. · · 2019 · cited 78× · PMID 31275265 · DOI 10.3389/fmicb.2019.01327
3. Influenza Polymerase Inhibitors: Mechanisms of Action and Resistance.
   Takashita E. · · 2021 · cited 60× · PMID 32122918 · DOI 10.1101/cshperspect.a038687
4. Drugs for Influenza Treatment: Is There Significant News?
   Principi N, Camilloni B, Alunno A, Polinori I, et al · · 2019 · cited 57× · PMID 31192211 · DOI 10.3389/fmed.2019.00109
5. Phase 2a, open-label, dose-escalating, multi-center pharmacokinetic study of favipiravir (T-705) in combination with oseltamivir in patients with severe influenza.
   Wang Y, Zhong W, Salam A, Tarning J, et al · · 2020 · cited 39× · PMID 33232871 · DOI 10.1016/j.ebiom.2020.103125
6. Influenza Therapeutics in Clinical Practice-Challenges and Recent Advances.
   Beigel JH, Hayden FG. · · 2021 · cited 37× · PMID 32041763 · DOI 10.1101/cshperspect.a038463
7. Preclinical and clinical developments for combination treatment of influenza.
   Koszalka P, Subbarao K, Baz M. · · 2022 · cited 30× · PMID 35551301 · DOI 10.1371/journal.ppat.1010481
8. Potential repurposing of Favipiravir in COVID-19 outbreak based on current evidence.
   Khambholja K, Asudani D. · · 2020 · cited 19× · PMID 32360327 · DOI 10.1016/j.tmaid.2020.101710