TerminatedPhase 2

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

Stopped: Part A and Part B were completed but Pfizer terminated Part C due to strategic consideration. There were no safety concerns in the decision to stop Part C and no changes to the risk-benefit for participants who received RV521 in the study.

Argentina, Canada, Chile51 participantsStarted 2019-11-13

Plain-language summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI

Who can participate

Age range1 Month – 36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female ≥ 1 month and ≤ 36 months of age
✓. Weight ≥ 3.5 kg
✓. Clinical diagnosis of LRTI
✓. A positive RSV diagnostic test
✓. Hospitalised because of RSV LRTI
✓. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit
✓. Expected to remain in hospital for a minimum of 3 days
✓. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol

Exclusion criteria

✕. Premature (gestational age less than 37 weeks) AND \<1 year of post-natal age
✕. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.

What they're measuring

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

Timeframe: From start of IMP on Day 1 up to Day 7

Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

Timeframe: From start of IMP on Day 1 up to Day 12

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

Timeframe: Baseline (pre-dose on Day 1)

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose

Timeframe: Anytime between 18 to 24 hours post-dose on Day 1

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose

Timeframe: At 48 hours post-dose on Day 1

Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

Timeframe: Baseline (pre-dose on Day 1)

Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10

Trial details

NCT IDNCT04225897

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-05

Results submitted2023-12-05

View on ClinicalTrials.gov More Respiratory Syncytial Virus (RSV) trials

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

Argentina, Canada, Chile51 participantsStarted 2019-11-13

Plain-language summary

Who can participate

Age range1 Month – 36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female ≥ 1 month and ≤ 36 months of age
✓. Weight ≥ 3.5 kg
✓. Clinical diagnosis of LRTI
✓. A positive RSV diagnostic test
✓. Hospitalised because of RSV LRTI
✓. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit
✓. Expected to remain in hospital for a minimum of 3 days
✓. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol

Exclusion criteria

✕. Premature (gestational age less than 37 weeks) AND \<1 year of post-natal age
✕. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.

What they're measuring

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

Timeframe: From start of IMP on Day 1 up to Day 7

Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

Timeframe: From start of IMP on Day 1 up to Day 12

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

Timeframe: Baseline (pre-dose on Day 1)

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose

Timeframe: Anytime between 18 to 24 hours post-dose on Day 1

Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose

Timeframe: At 48 hours post-dose on Day 1

Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

Timeframe: Baseline (pre-dose on Day 1)

Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10