UMEM Research Studies

SAPPHIRE

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, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection.

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 adolescent, adult, and elderly hospitalized participants with influenza A infection.

Study design: 

This double-blind 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.

Primary Endpoint(s): 

Participant's Clinical Status Assessed by Hospital Recovery Scale

Secondary Endpoints:

1- Measure of Safety and Tolerability: Number of Participants With Adverse Events, Laboratory abnormalities, Electrocardiogram (ECG) Abnormalities, Peripheral Capillary Oxygen Saturation (SpO2) abnormalities, and Vital Sign abnormalities as measures of safety and tolerability. 

2- Time From Study Drug Start to Hospital Discharge 

3- Time From Intensive Care Unit (ICU) Admission to ICU Discharge

4- Time From Start to End of Mechanical Ventilation 

5- Participant's Clinical Status Assessed by Hospital Recovery Scale 

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

7- Time to Return to Daily Activities 

8- Number of Participants with All-cause Mortality

9- Percentage of Participants Receiving Antibiotic Treatment 

10- Duration of Antibiotic Treatment 

11- Number of Participants Receiving Extended Treatment 

12- Number of Participants Requiring Re-hospitalization

13- Number of Participants not Hospitalized at Day 6

14- Time to Clinical Response 

15- Time to Respiratory Response 

16- Maximum Plasma Concentration (Cmax) of pimodivir

17- Trough Plasma Concentration (Ctrough) of Pimodivir

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

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

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

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

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