Influenza Clinical Trial
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.
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |