UMEM Research Studies

DIAMOND

Sponsor: Janssen Research & Development, LLC | Status: Terminated

Start Date: 01/01/2018 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)
Mike Winters

Description:

Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications

Primary Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM

Research Team: 

Dana Beach (dbeach3@som.umaryland.edu)

Kyra Lasko (kyra.lasko@som.umaryland.edu)

Youssef Annous (yannous@som.umaryland.edu)

Objectives: To evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in non-hospitalized participants with influenza A infection who are at risk of developing complications.

Study design: 

A double-blind study to evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (age greater than 65 but less than or equal to 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days
 

Primary Endpoint(s): 

Time to Resolution of Influenza-Related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)

 

Secondary Endpoints:

1- Measure of Safety and Tolerability: Number of Participants With Adverse Events, Laboratory abnormalities, Electrocardiogram (ECG) Abnormalities, and Vital Sign abnormalities as measures of safety and tolerability. 

2- Percentage of Participants Hospitalized 

3- Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment

4- Time to Return to Daily Activities 

5- Time to Resolution of Fever

6- Number of Participants with All-cause Mortality

7- Maximum Plasma Concentration (Cmax) of pimodivir

8- Trough Plasma Concentration (Ctrough) of Pimodivir

9- Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir

10- Area Under the Plasma Concentration- Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12)

11- Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire 

12- Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire

13- Number of Participants with Emergence of Viral Resistance to Pimodivir

14- Time to Influenza Viral Negativity

15- Viral Load Over Time

16- Time to Resolution of Each of the 10 Individual Influenza-Related Symptoms as Assessed by the PRO Measure Flu-iiQ

Keywords: Influenza A, Upper Respiratory Tract infection, URI, Pimodivir