Trial · NCT04225897
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
NCT04225897, Phase 2, Terminated, Pfizer; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. Trials, record NCT04225897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225897
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
- NCT number
- NCT04225897
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Respiratory Syncytial Virus (RSV), Lower Resp Tract Infection
- Interventions
- RV521, Placebo
- First posted
- 2020-01-13
- Last updated
- 2024-10-23
- Results first posted
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes78
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 7 | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event. |
| Primary | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 12 | An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Anytime between 18 to 24 hours post-dose on Day 1 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | At 48 hours post-dose on Day 1 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Primary | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Primary | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | Anytime between 4 to 5 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Primary | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | At 12 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 registered outcomesOutcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 7 | Safety population included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 12 | Safety population included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Anytime between 18 to 24 hours post-dose on Day 1 | Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | At 48 hours post-dose on Day 1 | Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | Safety population included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Time to Maximum Plasma Concentration (Tmax) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | Pharmacokinetic (PK) population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. | Hours | MEDIAN |
| SECONDARY | Part B: Time to Maximum Plasma Concentration (Tmax) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Hours | MEDIAN |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 outcomesResults by group2,214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 1.0 mg/kg | TEAEs | 2 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 2.0 mg/kg | TEAEs | 5 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 2.5 mg/kg | TEAEs | 3 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 2: RV521 2.0 mg/kg | TEAEs | 1 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 1.0 mg/kg | SAEs | 0 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 2.0 mg/kg | SAEs | 1 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 2.5 mg/kg | SAEs | 0 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 2: RV521 2.0 mg/kg | SAEs | 0 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 1.0 mg/kg | TEAEs leading to permanent discontinuation of IMP | 0 | Participants | |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | Cohort 1: RV521 2.0 mg/kg | TEAEs leading to permanent discontinuation of IMP | 0 | Participants |
1 to 10 of 2,214Source ClinicalTrials.gov
See all 2,214 results by groupParticipant flow96
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Screening Visit to Day 7) | STARTED | Cohort 1: RV521 1.0 mg/kg | 3 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 1: RV521 2.0 mg/kg | 7 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 1: RV521 2.5 mg/kg | 3 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 2: RV521 2.0 mg/kg | 6 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 3: Placebo | 0 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 3: RSV1 2.5 mg/kg | 0 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 3: RV521 3.5 mg/kg | 0 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 3: RV521 5 mg/kg | 0 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 4: Placebo | 0 | |
| Part A (Screening Visit to Day 7) | STARTED | Cohort 4: RV521 2.5 mg/kg | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 participant flowAdverse events420
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Part A: Cohort 1: RV521 1.0 mg/kg | 0 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Part A: Cohort 1: RV521 2.0 mg/kg | 0 | 7 | |
| other | Vomiting | Gastrointestinal disorders | Part A: Cohort 1: RV521 2.5 mg/kg | 3 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Part A: Cohort 2: RV521 2.0 mg/kg | 0 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 3: Placebo | 0 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 3: RSV1 2.5 mg/kg | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 3: RV521 3.5 mg/kg | 0 | 4 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 3: RV521 5 mg/kg | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 4: Placebo | 0 | 1 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Cohort 4: RV521 2.5 mg/kg | 0 | 4 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Cohort 1: RV521 1.0 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part A: Cohort 1: RV521 2.0 mg/kg | 0 | 7 |
| Total, all-cause mortality | Part A: Cohort 1: RV521 2.5 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part A: Cohort 2: RV521 2.0 mg/kg | 0 | 6 |
| Total, all-cause mortality | Part B: Cohort 3: Placebo | 0 | 3 |
| Total, all-cause mortality | Part B: Cohort 3: RSV1 2.5 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part B: Cohort 3: RV521 3.5 mg/kg | 0 | 4 |
| Total, all-cause mortality | Part B: Cohort 3: RV521 5 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part B: Cohort 4: Placebo | 0 | 1 |
| Total, all-cause mortality | Part B: Cohort 4: RV521 2.5 mg/kg | 0 | 4 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04225897
GET https://conductscience.org/api/trials/v1/NCT04225897/registered?page=2