Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection (NCT NCT03376321)

Last Updated: 2025-02-04

Results Overview

The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

334 participants

Primary outcome timeframe

Day 6

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Pimodivir + SOC Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Study STARTED	168	166
Overall Study Treated	163	163
Overall Study COMPLETED	145	141
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Pimodivir + SOC Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Overall Study Other	5	1
Overall Study Withdrawal by Subject	8	14
Overall Study Lost to Follow-up	1	7
Overall Study Death	4	0
Overall Study Randomized, not treated	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pimodivir + SOC n=163 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=163 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Total n=326 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 15.46 • n=5 Participants	57.7 years STANDARD_DEVIATION 16.88 • n=7 Participants	58.7 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	75 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	88 Participants n=7 Participants	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	132 Participants n=7 Participants	264 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	113 Participants n=5 Participants	114 Participants n=7 Participants	227 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment ARGENTINA	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment AUSTRALIA	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment AUSTRIA	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment BELGIUM	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment BRAZIL	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment BULGARIA	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment CANADA	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment CHILE	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment FRANCE	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment GERMANY	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment INDIA	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment ISRAEL	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment ITALY	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment LATVIA	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment LITHUANIA	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment MALAYSIA	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment MEXICO	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment NETHERLANDS	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment NEW ZEALAND	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment POLAND	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment SINGAPORE	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment SLOVAKIA	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment SOUTH AFRICA	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment SPAIN	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment SWEDEN	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment TAIWAN	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment THAILAND	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment TURKEY	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment UKRAINE	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment UNITED STATES	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment VIETNAM	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 6

Population: Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=152 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=145 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza >72h: Death	1 Participants	0 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Not hospitalized	73 Participants	69 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Non-ICU hospitalization, not requiring supplemental oxygen	50 Participants	42 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Non-ICU hospitalization, requiring supplemental oxygen	18 Participants	25 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Admitted to the ICU, not requiring invasive mechanical ventilation	6 Participants	6 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Requiring invasive mechanical ventilation	2 Participants	3 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Any time since onset influenza: Death	3 Participants	0 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza less than or equal to (<=)72 hour (h): Not hospitalized	61 Participants	56 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza <=72h: Non-ICU hospitalization, not requiring supplemental oxygen	38 Participants	32 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza <=72h: Non-ICU hospitalization, requiring supplemental oxygen	15 Participants	19 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza <=72h: Admitted to the ICU, not requiring invasive mechanical ventilation	4 Participants	5 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza <=72h: Requiring invasive mechanical ventilation	2 Participants	2 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza <=72h: Death	2 Participants	0 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza greater than (>) 72h: Not hospitalized	12 Participants	13 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza >72h: Non-ICU hospitalization, not requiring supplemental oxygen	12 Participants	10 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza >72h: Non-ICU hospitalization, requiring supplemental oxygen	3 Participants	6 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza >72h: Admitted to the ICU, not requiring invasive mechanical ventilation	2 Participants	1 Participants
Number of Participants With Hospital Recovery Scale on Day 6 Time since onset influenza >72h: Requiring invasive mechanical ventilation	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND (randomized participants with a randomization date time at or before the date time of first intake of study drug, or with a randomization date time and no study drug intake) analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment.

The time to hospital discharge was defined as the time from start of study drug to hospital discharge.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=159 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=159 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Time to Hospital Discharge	113 hours Interval 94.2 to 118.5	108 hours Interval 92.7 to 116.3

SECONDARY outcome

Timeframe: Up to Day 33

Population: The Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A and were analyzed by planned treatment. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.

Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia \[including pneumonia attributable to unusual pathogens\], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease \[COPD\] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases \[for example, myocardial infarction, congestive heart failure, arrhythmia, stroke\], muscular disorders \[for example, myositis, rhabdomyolysis\], central nervous system \[CNS\] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections \[for example, sinusitis and otitis\]).

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=159 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=159 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Adjudicated Influenza Complications Any time since onset influenza	28 Participants	29 Participants
Number of Participants With Adjudicated Influenza Complications Time since onset influenza <=72h	24 Participants	24 Participants
Number of Participants With Adjudicated Influenza Complications Time since onset influenza >72h	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19

Population: Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category.

Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=153 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=151 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Viral Load Over Time Baseline	5.657 Log 10 viral particles per milliliter Standard Deviation 1.4693	5.655 Log 10 viral particles per milliliter Standard Deviation 1.4117
Viral Load Over Time Day 1	5.433 Log 10 viral particles per milliliter Standard Deviation 1.3102	6.410 Log 10 viral particles per milliliter Standard Deviation 0.7826
Viral Load Over Time Day 2	4.561 Log 10 viral particles per milliliter Standard Deviation 1.5133	4.794 Log 10 viral particles per milliliter Standard Deviation 1.4154
Viral Load Over Time Day 3	3.913 Log 10 viral particles per milliliter Standard Deviation 1.4202	4.057 Log 10 viral particles per milliliter Standard Deviation 1.3425
Viral Load Over Time Day 4	3.460 Log 10 viral particles per milliliter Standard Deviation 1.4952	3.634 Log 10 viral particles per milliliter Standard Deviation 1.2207
Viral Load Over Time Day 5	3.133 Log 10 viral particles per milliliter Standard Deviation 1.3500	3.157 Log 10 viral particles per milliliter Standard Deviation 1.1112
Viral Load Over Time Day 6	2.552 Log 10 viral particles per milliliter Standard Deviation 0.7100	2.876 Log 10 viral particles per milliliter Standard Deviation 0.9750
Viral Load Over Time Day 7	2.103 Log 10 viral particles per milliliter Standard Deviation 0.0350	2.269 Log 10 viral particles per milliliter Standard Deviation 0.3829
Viral Load Over Time Day 8	2.386 Log 10 viral particles per milliliter Standard Deviation 0.7052	2.463 Log 10 viral particles per milliliter Standard Deviation 0.7051
Viral Load Over Time Day 9	2.050 Log 10 viral particles per milliliter Standard Deviation 0.0000	2.611 Log 10 viral particles per milliliter Standard Deviation 0.8281
Viral Load Over Time Day 10	2.287 Log 10 viral particles per milliliter Standard Deviation 0.6518	2.346 Log 10 viral particles per milliliter Standard Deviation 0.6357
Viral Load Over Time Day 11	2.050 Log 10 viral particles per milliliter	—
Viral Load Over Time Day 14	2.137 Log 10 viral particles per milliliter Standard Deviation 0.4163	2.116 Log 10 viral particles per milliliter Standard Deviation 0.2109
Viral Load Over Time Day 19	2.050 Log 10 viral particles per milliliter Standard Deviation 0.0000	2.050 Log 10 viral particles per milliliter Standard Deviation 0.0000

SECONDARY outcome

Timeframe: Up to Day 33

Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=163 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=163 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	85 Participants	84 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: Intent-To-Treat infected (ITT-i) set includes all participants from the RAND analysis set who received at least 1 dose of study drug and who had a confirmed infection with influenza A.

Emergence of viral resistance to Pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=159 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=159 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Emergence of Viral Resistance to Pimodivir Polymerase basic protein (PB) 2 region: With emerging mutations of interest	2 Participants	0 Participants
Number of Participants With Emergence of Viral Resistance to Pimodivir Neuraminidase (NA) region: With emerging mutations of interest	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose

Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. "n (number analyzed)" is defined as number of participants analyzed for specified category.

Plasma concentration of Pimodivir was reported.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=141 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Plasma Concentration of Pimodivir Day 1: 1 hour30minutes to 6 hours postdose	1696.3 Nanogram per milliliter (ng/mL) Standard Deviation 2298.4	—
Plasma Concentration of Pimodivir Day 3: Pre-Dose	854.3 Nanogram per milliliter (ng/mL) Standard Deviation 898.3	—
Plasma Concentration of Pimodivir Day 5: Pre-Dose	940.3 Nanogram per milliliter (ng/mL) Standard Deviation 1081.1	—
Plasma Concentration of Pimodivir Day 5: 1 hour30minutes to 6 hours postdose	3046.7 Nanogram per milliliter (ng/mL) Standard Deviation 3860.5	—
Plasma Concentration of Pimodivir Day 6: 12hours post dose	938.2 Nanogram per milliliter (ng/mL) Standard Deviation 1374.7	—

SECONDARY outcome

Timeframe: Up to Day 33

Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.

Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis were collected at predefined time points for clinical laboratory testing.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=163 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=163 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Clinically Significant Changes in Laboratory Tests	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.

Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=163 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=163 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 33

Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.

Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) was reported.

Outcome measures

Outcome measures
Measure	Pimodivir + SOC n=163 Participants Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid.	Placebo + SOC n=163 Participants Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants	0 Participants

Adverse Events

Pimodivir + SOC

Serious events: 13 serious events

Other events: 81 other events

Deaths: 4 deaths

Placebo + SOC

Serious events: 15 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Director Medical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Pimodivir + SOC n=163 participants at risk Participants received 600 milligram (mg) Pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment. Eligible participants were given an optional treatment extension of 5 days bid	Placebo + SOC n=163 participants at risk Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment. Eligible participants were given an optional treatment extension of 5 days bid.
Cardiac disorders Acute Left Ventricular Failure	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Cardiac disorders Cardiac Arrest	1.2% 2/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Cardiac disorders Cardiac Failure	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Cardiac disorders Cardiac Failure Congestive	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Cardiac disorders Left Ventricular Failure	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Gastrointestinal disorders Diarrhoea	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Immune system disorders Drug Hypersensitivity	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Abscess Limb	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Parotitis	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Pneumonia	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Pneumonia Bacterial	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Pneumonia Escherichia	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Pneumonia Klebsiella	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Pneumonia Pneumococcal	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Postoperative Wound Infection	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Respiratory Tract Infection	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Infections and infestations Septic Shock	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Renal and urinary disorders Urinary Retention	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Aspiration	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Respiratory, thoracic and mediastinal disorders Wheezing	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Vascular disorders Venous Thrombosis Limb	0.61% 1/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.	0.00% 0/163 • Up to Day 33 The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.