Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.


Clinical Trial Description

This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03376321
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Terminated
Phase Phase 3
Start date January 3, 2018
Completion date April 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT03999554 - Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines Phase 1
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Completed NCT02487173 - Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B N/A
Completed NCT01701752 - Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults Phase 1
Enrolling by invitation NCT03207152 - Biomarkers Predicting Infectivity in an Experimental Human Influenza Model Phase 1
Terminated NCT05567783 - A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A Phase 2
Not yet recruiting NCT00987012 - The Influence of Fortified Pomegranate Juice (Punica Granatum) on Seasonal Influenza and Swine Flu Patients N/A
Not yet recruiting NCT05928507 - FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Completed NCT03651544 - The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Phase 1
Completed NCT02623322 - A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults Phase 2
Completed NCT03196661 - Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population Phase 1
Recruiting NCT06160531 - Influenza Viral Challenge Study of CC-42344 in Healthy Participants Phase 2
Recruiting NCT06191393 - SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings N/A
Completed NCT06127108 - Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel N/A
Completed NCT05163730 - Clinical Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel N/A
Not yet recruiting NCT06392451 - LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia N/A
Recruiting NCT04896853 - Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans® Phase 1
Not yet recruiting NCT05787444 - Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), and/or Influenza B (Flu B)
Completed NCT05354115 - Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel. N/A
Completed NCT02014870 - Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers Phase 1