Trial Outcomes & Findings for Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV) (NCT NCT06067191)

Last Updated: 2024-10-21

Results Overview

Area under the curve (AUC) for RSV viral load measured in nasal washes by qRT-PCR in participants inoculated with RSV-A Memphis 37b, from initial administration of IMP up to the morning of Day 12 (Quarantine discharge) was presented in this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

82 participants

Primary outcome timeframe

From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)

Results posted on

2024-10-21

Participant Flow

A total of 82 healthy participants were enrolled in the study and received Respiratory Syncytial Virus (RSV) - A Memphis 37b virus inoculation (challenge agent) intranasally on Day 0. Three participants withdrew from study (2 withdrew consent and 1 not randomized because of influenza infection) before randomization and a total of 79 participants were randomized in the study.

Participant milestones

Participant milestones
Measure	RV299 Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Overall Study STARTED	39	40
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RV299 Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Safety, Pharmacokinetics,and Antiviral Activity of RV299 Against Respiratory Syncytical Virus (RSV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=40 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.	Total n=79 Participants Total of all reporting groups
Age, Continuous	25.7 Years STANDARD_DEVIATION 6.21 • n=5 Participants	26.2 Years STANDARD_DEVIATION 7.29 • n=7 Participants	25.9 Years STANDARD_DEVIATION 6.74 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: From initial administration of IMP up to the morning of quarantine discharge (up to Day 12)

Population: Intent-to-Treat Infected (ITT-I) Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)	350.99 Hours*log10 copies per milliliter Standard Deviation 289.79	616.97 Hours*log10 copies per milliliter Standard Deviation 374.143

SECONDARY outcome

Timeframe: From initial administration of IMP up to planned discharge from quarantine (Up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Peak viral load of RSV as defined by the maximum viral load determined by qRT-PCR measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Peak Viral Load of RSV Determined by qRT-PCR	5.01 Log10 copies per milliliter Standard Deviation 1.968	6.23 Log10 copies per milliliter Standard Deviation 1.735

SECONDARY outcome

Timeframe: From first administration of IMP to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

The time from the first administration of IMP to the first confirmed negative qRT-PCR test after the peak qRT-PCR measurement was calculated as: Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Initial Administration of Investigational Medicinal Product (IMP) to First Confirmed Undetectable Assessment After Peak Measure	4.2 Days Interval 2.0 to 6.5	8.5 Days Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: From peak qRT-PCR measurement to the first confirmed negative qRT-PCR test or censoring date (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

The time from the peak qRT-PCR measurement after administration of IMP to the first confirmed negative qRT-PCR test was calculated as (Date and time of first confirmed negative test after peak qRT-PCR measurement minus Date and time of peak qRT-PCR measurement). A negative test was defined as two consecutive 'Not Detected' results in the qRT-PCR test. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants without a confirmed undetectable assessment after their peak, were censored at their last detected qRT-PCR assessment.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Confirmed Negative Test by qRT-PCR Measurement Starting From Peak qRT-PCR After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure	2.5 Days Interval 1.5 to 4.5	5.0 Days Interval 2.5 to Upper limit of interquartile range could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first administration of IMP to peak qRT-PCR measurement (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

The time to the peak qRT-PCR measurement starting from the initial administration of IMP was calculated as: Date and time of peak qRT-PCR measurement minus Date and time of first IMP administration. The peak qRT-PCR was defined as the highest viral load value obtained by a participant after their first administration of IMP.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Peak qRT-PCR Starting From Initial Administration of IMP	1.5 Days Interval 0.5 to 2.0	1.5 Days Interval 1.5 to 4.0

SECONDARY outcome

Timeframe: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Area under the viral load-time curve (VL-AUC) of RSV challenge virus as determined by viral culture on nasal samples, starting at initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Viral Load-Time Curve (VL-AUC) for RSV-A Memphis 37b Determined by Viral Culture	106.48 Hours*log10 plaque forming units/mL Standard Deviation 133.187	212.51 Hours*log10 plaque forming units/mL Standard Deviation 170.700

SECONDARY outcome

Timeframe: From initial administration of IMP up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Peak viral load of RSV as defined by the maximum viral load determined by viral culture measurements in nasal samples starting from initial administration of IMP up to planned discharge from quarantine was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Peak Viral Load of RSV Determined by Viral Culture	2.43 Log10 plaque forming units/mL Standard Deviation 2.030	3.63 Log10 plaque forming units/mL Standard Deviation 2.285

SECONDARY outcome

Timeframe: From initial administration of IMP up to first confirmed undetectable assessment or censoring date (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Time to confirmed negative test by viral culture measurements in nasal samples from initial administration of IMP up to first confirmed negative viral culture measurement after the peak viral culture measurement was calculated as: Date and time of first confirmed negative test after peak viral culture measurement minus Date and time of first IMP administration. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Confirmed Negative Test by Viral Culture Measurement Starting From at Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure	3.2 Days Interval 2.5 to 3.8	5.0 Days Interval 3.6 to 6.0

SECONDARY outcome

Timeframe: From peak qRT-PCR measurement to first confirmed undetectable assessment or censoring date (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

The time from the peak viral culture measurement after administration of IMP to the first confirmed negative viral culture measurement was calculated in days as: Date of and time first confirmed negative test minus Date and time of peak qRT-PCR measurement. A negative test was defined as two consecutive 'Not Detected' results in the viral culture test. The peak viral culture measurement was defined as the highest viral load value obtained by a participant after their first administration of IMP. Participants who did not have a confirmed undetectable assessment after their peak viral culture measurement after first administration of IMP were censored at their last detectable assessment.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Confirmed Negative Test by Viral Culture Measurement Starting From Peak Viral Culture After Initial Administration of IMP to First Confirmed Undetectable Assessment After Peak Measure	1.3 Days Interval 0.7 to 2.5	1.6 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Area under the Curve over Time of Total Clinical Symptoms (TSS-AUC) as measured from 10 symptoms within Graded Symptom Scoring System Collected 3 Times Daily Starting at Initial Administration up to Planned Discharge from Quarantine. TSS (from 10 items of the 13-item symptom diary card) was used to calculate the AUC, from the assessment nearest to the time of the first administration of IMP until Day 12. Following types of symptoms were recorded on symptom diary cards: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), higher scores = greater severity of symptoms. Total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Curve Over Time of Total Clinical Symptoms as Measured From 10 Symptoms Within the Graded Symptom Scoring System	180.77 Hours*score Standard Deviation 242.274	240.94 Hours*score Standard Deviation 224.439

SECONDARY outcome

Timeframe: Baseline (assessment nearest to the time of the first administration of IMP) up to Day 12

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Area under the curve over time of total clinical symptoms change from baseline (TSS-AUC-CFB) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting at initial administration of IMP up to planned discharge from quarantine (Day 12, am). The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. TSS was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The AUC calculation was based on the available non-missing calculated total symptom scores between the start and end of the defined AUC time.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Curve Over Time of Total Clinical Symptoms Change From Baseline (TSS-AUC-CFB) as Measured From 10 Symptoms Within the Graded Symptom Scoring System	-17.23 Hours*score Standard Deviation 202.602	103.75 Hours*score Standard Deviation 212.465

SECONDARY outcome

Timeframe: From initial administration of IMP (before or after administration) up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Peak total clinical symptoms (TSS) as measured from 10 symptoms within the graded symptom scoring system collected 3 times daily starting from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The overall peak score was defined as the highest scoring symptom diary card observed from the first administration of IMP until quarantine discharge.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Overall Peak Total Clinical Symptoms (TSS) Score	3.30 Units on a scale Standard Deviation 2.835	3.90 Units on a scale Standard Deviation 3.063

SECONDARY outcome

Timeframe: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 (days relative to first administration of IMP)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Individual maximum daily sum of symptom score from initial administration of IMP up to planned discharge from quarantine. The following types of symptoms were recorded: Upper Respiratory Tract (URT): runny nose, stuffy nose, sore throat, sneezing, earache; Lower Respiratory Tract (LRT): cough, shortness of breath; Systemic: headache, malaise, muscle/joint ache/stiffness. Each symptom was recorded on a grading scale of 0 to 3 (or 0 to 4 for the Shortness of Breath symptom), where higher scores indicated greater severity of symptoms. The total symptom score was calculated as sum of the 10 observed symptom grade values and ranged from 0 to 31, where higher scores indicated more severe symptoms. The highest total symptom score recorded on each day, across the three assessments was reported in this outcome measure. The peak daily score was defined as the highest scoring symptom diary card observed on each day from the first administration of IMP until quarantine discharge.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Individual Maximum Daily Peak Symptom Score Day 0	2.1 Units on a scale Standard Deviation 2.32	1.2 Units on a scale Standard Deviation 1.70
Individual Maximum Daily Peak Symptom Score Day 1	2.0 Units on a scale Standard Deviation 2.70	1.8 Units on a scale Standard Deviation 2.12
Individual Maximum Daily Peak Symptom Score Day 2	1.9 Units on a scale Standard Deviation 2.73	3.0 Units on a scale Standard Deviation 3.01
Individual Maximum Daily Peak Symptom Score Day 3	1.9 Units on a scale Standard Deviation 2.83	2.6 Units on a scale Standard Deviation 2.54
Individual Maximum Daily Peak Symptom Score Day 4	1.1 Units on a scale Standard Deviation 1.71	2.1 Units on a scale Standard Deviation 2.17
Individual Maximum Daily Peak Symptom Score Day 5	0.7 Units on a scale Standard Deviation 1.27	1.6 Units on a scale Standard Deviation 2.11
Individual Maximum Daily Peak Symptom Score Day 6	0.6 Units on a scale Standard Deviation 1.12	1.0 Units on a scale Standard Deviation 1.86
Individual Maximum Daily Peak Symptom Score Day 7	0.6 Units on a scale Standard Deviation 1.16	1.1 Units on a scale Standard Deviation 1.53
Individual Maximum Daily Peak Symptom Score Day 8	1.0 Units on a scale Standard Deviation 1.22	0.4 Units on a scale Standard Deviation 0.51
Individual Maximum Daily Peak Symptom Score Day 9	0.0 Units on a scale Standard Deviation 0.0	0.0 Units on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: From first administration of IMP until time of symptom resolution or censoring date (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection. Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the assessment at the time of the first administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of assessment at IMP administration. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment.

Outcome measures

Outcome measures
Measure	RV299 n=19 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=25 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Symptom Resolution Starting at Initial Administration of IMP to 24 Hours Symptom Free	3.99 Days Interval 1.45 to 6.65	6.40 Days Interval 4.48 to 7.99

SECONDARY outcome

Timeframe: From time of highest total symptom score until time of symptom resolution or censoring date (up to Day 12)

Symptom resolution was defined as a participant scoring 0 for the total symptom score for a 24-hour period (e.g., a minimum of three consecutive symptom diary cards, each with a score of 0) after their peak symptom score. The time from the highest total symptom score following administration of IMP until symptom resolution was calculated as: Date and time of symptom resolution minus Date and time of highest total symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants who did not record 24 hours symptom free after their highest total symptom score during the quarantine period were censored at their last assessment.

Outcome measures

Outcome measures
Measure	RV299 n=19 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=25 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Symptom Resolution Starting at Peak Symptoms After Initial Administration to 24 Hours Symptom Free	1.44 Days Interval 0.67 to 3.66	3.67 Days Interval 2.37 to 4.64

SECONDARY outcome

Timeframe: From first dose of IMP until time of highest total symptom score or censoring date (Up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Time to peak as measured from 10 symptoms within the graded daily symptom scoring system starting from initial administration of IMP to the time of peak daily symptom score. If the peak symptom score occurred on more than one day then the first occurrence was selected. Participants were censored at their last assessment if they did not record any symptoms during the quarantine period.

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Peak Symptom Score From Initial Administration of IMP	1.61 Days Interval 0.42 to 4.63	2.74 Days Interval 1.99 to 3.97

SECONDARY outcome

Timeframe: From first administration of IMP up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Total weight of nasal mucus was calculated as the sum of mucus weights taken from the assessment at the time of the first administration of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge).

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Total Weight of Mucus Produced Starting at Initial Administration of IMP up to Planned Discharge From Quarantine	7.49 Grams Standard Deviation 14.516	16.23 Grams Standard Deviation 21.850

SECONDARY outcome

Timeframe: From first administration of IMP up to planned discharge from quarantine (up to Day 12)

Population: ITT-I Population consisted of all randomized participants who received challenge virus and at least 1 dose of IMP and met the criterion for RSV infection.

Total number of tissues was counted from the assessment at the time of the first dose of IMP (prior to or after dosing, depending on whether dosed in the morning or evening) to morning of Day 12 (Quarantine discharge).

Outcome measures

Outcome measures
Measure	RV299 n=23 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=29 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Total Number of Tissues Used by Participants Starting At Initial Administration of IMP up to Planned Discharge From Quarantine	14.09 Tissues Standard Deviation 21.067	28.17 Tissues Standard Deviation 33.078

SECONDARY outcome

Timeframe: From first dose of IMP until end of follow-up visit (up to Day 28)

Population: Safety analysis population was defined as all randomized participants who received challenge virus and at least 1 dose of IMP.

An adverse event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or important medical event.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=40 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Event	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Event	12 Participants	12 Participants

SECONDARY outcome

Timeframe: From viral challenge on Day 0 up to end of follow-up (Day 28)

Population: Safety analysis population was defined as all randomised participants who received challenge virus and at least 1 dose of IMP.

An Adverse Event was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the study intervention. Number of participants with AEs possibly, probably or definitely related to viral challenge agents were reported by preferred terms in this outcome measure.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=40 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Number of Participants With AEs Related to Viral Challenge Musculoskeletal pain (Possibly Related)	1 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Tachycardia (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Tachycardia (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Tachycardia (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Upper respiratory tract infection (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Upper respiratory tract infection (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Upper respiratory tract infection (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Headache (Possibly Related)	2 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Headache (Probably Related)	0 Participants	1 Participants
Number of Participants With AEs Related to Viral Challenge Headache (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Ageusia (Possibly Related)	0 Participants	1 Participants
Number of Participants With AEs Related to Viral Challenge Ageusia (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Ageusia (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Anosmia (Possibly Related)	0 Participants	1 Participants
Number of Participants With AEs Related to Viral Challenge Anosmia (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Anosmia (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Syncope (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Syncope (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Nausea (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Nausea (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Nausea (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Abdominal distension (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Abdominal distension (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Abdominal distension (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Diarrhoea (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Diarrhoea (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Diarrhoea (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Mouth ulceration (Possibly Related)	1 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Mouth ulceration (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Mouth ulceration (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Malaise (Possibly Related)	2 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Malaise (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Malaise (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chest discomfort (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chest discomfort (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chills (Possibly Related)	1 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chills (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chills (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Dyspnoea (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Dyspnoea (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Cough (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Cough (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Electrocardiogram T wave abnormal (Possibly Related)	0 Participants	1 Participants
Number of Participants With AEs Related to Viral Challenge Syncope (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Chest discomfort (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Dyspnoea (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Cough (Possibly Related)	0 Participants	1 Participants
Number of Participants With AEs Related to Viral Challenge Electrocardiogram T wave abnormal (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Electrocardiogram T wave abnormal (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Platelet count decreased (Possibly Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Platelet count decreased (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Platelet count decreased (Definitely Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Musculoskeletal pain (Probably Related)	0 Participants	0 Participants
Number of Participants With AEs Related to Viral Challenge Musculoskeletal pain (Definitely Related)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From viral challenge on Day 0 up to end of follow-up (Day 28)

Population: Safety analysis population was defined as all randomized participants who received challenge virus and at least 1 dose of IMP.

Number of participants with concomitant medications were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=40 Participants Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Number of Participants With Concomitant Medications	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96-hours post-dose 1 and dose 10

Population: Pharmacokinetic (PK) population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Time to Maximum Plasma Concentration (Tmax) for RV299 Dose 1	2.85 Hours Interval 0.93 to 10.0	—
Time to Maximum Plasma Concentration (Tmax) for RV299 Dose 10	2.45 Hours Interval 0.92 to 12.13	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10

Population: PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. Here, 'Number Analyzed' signifies participants evaluable for specified timepoints. t1/2 for dose 1 could not be calculated as at least 3 data points were required in terminal elimination phase within same participant; this criteria could not be fulfilled due to insufficient data above limit of quantification.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Terminal Half-Life (t1/2) for RV299 Dose 1	NA Hours Geometric Coefficient of Variation NA t1/2 for dose 1 data could not be calculated as the percentage AUC extrapolated was greater than 20% and also due to inadequate characterization of the terminal elimination phase.	—
Terminal Half-Life (t1/2) for RV299 Dose 10	12.1 Hours Geometric Coefficient of Variation 6.0	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1 and dose 10

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Maximum Observed Plasma Concentration for RV299 Dose 1	448 Nanograms per milliliter Geometric Coefficient of Variation 155	—
Maximum Observed Plasma Concentration for RV299 Dose 10	1144 Nanograms per milliliter Geometric Coefficient of Variation 647	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12 hours post-dose 1 and dose 10

Area under the plasma concentration-time curve from time zero to the end of the dosing interval for RV299 where dosing interval=12 hours.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299 Dose 1	3500 Hours*nanograms per milliliter Geometric Coefficient of Variation 825	—
Area Under the Plasma Concentration-Time Curve From Time Zero to the End of the Dosing Interval for RV299 Dose 10	7845 Hours*nanograms per milliliter Geometric Coefficient of Variation 3004	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24 hours post-dose 1 and dose 10

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Plasma Concentration-Time Curve Over the Last 24 Hours Dosing Interval for RV299	NA Hours*nanograms per milliliter Geometric Coefficient of Variation NA AUC24 over the dosing interval could not be computed as the dosing interval was not 24 hours.	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8,10, 12, 24, 36, 48, 60, 72, 84 and 96 hours post-dose 1

Population: PK population consisted of all participants from ITT population (all randomized participants who received challenge virus and at least 1 dose of IMP) with at least one post-dose PK result. AUC(0-infinity) could not be calculated as atleast 3 data points are required in terminal elimination phase within same participant; this criteria could not be fulfilled due to insufficient data above limit of quantification and did not include a characterization of the terminal elimination.

Outcome measures

Outcome measures
Measure	RV299 n=39 Participants Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for RV299 on Day 1	NA Hours*nanograms per milliliter Geometric Coefficient of Variation NA Data could not be calculated as the percentage AUC extrapolated was greater than 20% and also due to inadequate characterization of the terminal elimination phase.	—

Adverse Events

RV299

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	RV299 n=39 participants at risk Participants were administered an oral suspension of 65 milligrams (mg) RV299 twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered RV299 from Day 5.	Placebo n=40 participants at risk Participants were administered an oral suspension of placebo twice daily at an interval of approximately 12 hours for 5 consecutive days from Day 2 following confirmation of RSV infection. Participants without a positive result for RSV infection were administered placebo from Day 5.
Nervous system disorders Headache	5.1% 2/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	5.0% 2/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Nervous system disorders Dizziness	5.1% 2/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Nervous system disorders Ageusia	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Nervous system disorders Anosmia	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Nervous system disorders Syncope	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
General disorders Vessel puncture site bruise	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	5.0% 2/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
General disorders Chills	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
General disorders Malaise	5.1% 2/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
General disorders Vessel puncture site haematoma	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Infections and infestations Upper respiratory tract infection	5.1% 2/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	5.0% 2/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Infections and infestations Urinary tract infection	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Gastrointestinal disorders Nausea	5.1% 2/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Gastrointestinal disorders Diarrhoea	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Gastrointestinal disorders Mouth ulceration	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Investigations Blood potassium increased	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Investigations Electrocardiogram T wave abnormal	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Investigations Platelet count decreased	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Skin and subcutaneous tissue disorders Rash	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Cardiac disorders Bundle branch block	0.00% 0/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	2.5% 1/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)
Reproductive system and breast disorders Dysmenorrhoea	2.6% 1/39 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)	0.00% 0/40 • From first dose of IMP until end of follow-up visit (up to Day 28) and from viral challenge on Day 0 up to end of follow-up (Day 28)