A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. (REVIRAL 1)

A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)

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

Study Overview

• Status: Terminated
• Conditions: Lower Resp Tract Infection; Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Drug: RV521; Drug: Placebo

Detailed Description

This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI.

The clinical study consists of 3 parts, the third part (Part C) is optional:

• Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 & 2)
• Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 & 5)
• Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI I The number of subjects enrolled in Parts A and B of the study will depend on the safety and PK data from the group of subjects enrolled in specified age cohorts and the subsequent recommendation of the Data Safety Monitoring Committee (DSMC).

The DSMC may recommend a dose adjustment (either a reduction or an escalation) and/or regimen adjustment (Part B only) for subsequent subjects because of the observation of an unexpected safety/tolerability profile and/or differences between the observed and predicted exposure resulting from a specified dose of RV521.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sally Rees, MPhil; Phone Number: +44 (0)1438 906760; Email: Sally.Rees@pfizer.com

Study Locations

• Argentina
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, B8001HXM
      • Hospital Italiano Regional del Sur
    • Bahia Blanca, Buenos Aires, Argentina, B8001DDU
      • Hospital Interzonal General de Agudos "Dr. José Penna"
  • Caba
    • Ciudad Autonoma de Buenos Aires, Caba, Argentina, C1270AAN
      • Hospital General de Niños Pedro de Elizalde
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Hospital de Niños "Ricardo Gutiérrez"
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8380418
      • Hospital de Ninos Dr. Roberto del Rio
  • Region DE LOS Lagos
    • Osorno, Region DE LOS Lagos, Chile, 5311523
      • Hospital Base San José Osorno
• Costa Rica
  • San Jose, Costa Rica
    • Hospital Clínica Biblica
  • San Jose, Costa Rica
    • Corporacion Gihema
  • San Jose, Costa Rica
    • Hospital Metropolitano, Sede San Jose
  • San Jose, Costa Rica
    • lnstituto de lnvestigacion en Ciencias Medicas(IICIMED)
  • San Jose, Costa Rica
    • Policlinico San Bosco, Consultorio de Pediatria, Dr. Arturo Solis Moya
• Hungary
  • Budapest, Hungary, 1094
    • Semmelweis Egyetem 11.sz. Gyermeklinika
  • Budapest, Hungary, 1125
    • Eszak-Kozep-budai Centrum,Uj Szent Janos Korhaz es Szakrendelo,Gyermekosztaly
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház
• Israel
  • Beer-Sheva, Israel, 84417
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Petach Tikava, Israel, 49202
    • Schneider Children's Medical Center of Israel
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Children's Hospital
  • Seoul, Korea, Republic of, 04401
    • Department of Pediatrics, SoonchunHyang University Seoul Hospital
• Malaysia
  • Parek, Malaysia, 32040
    • Hospital Seri Manjung
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab II
  • Perak
    • Taiping, Perak, Malaysia, 34000
      • Hospital Taiping
  • Pulau Pinang
    • Seberang Jaya, Pulau Pinang, Malaysia, 13700
      • Hospital Seberang Jaya
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital
    • Sibu, Sarawak, Malaysia, 96000
      • Hospital Sibu
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia, 20400
      • Hospital Sultanah Nur Zahirah
• New Zealand
  • Wellington
    • Riddiford Street, Wellington, New Zealand, 6021
      • Capital and Coast DHB, Wellington Hospital
• Panama
  • Panama, Panama
    • Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
  • Panama, Panama
    • Hospital del Nino Dr. Jose Renan Esquivel
  • Panama, Panama
    • Hospital Materno Infantil Jose Domingo de Obaldia
• Poland
  • Krakow, Poland, 30-663
    • Uniwersytecki Szpital Dzieciecy w Krakowie
  • Lodz, Poland, 93-338
    • lnstytut Centrum Zdrowia Matki Polki Klinika Pediatrii, Immunologii i Nefrologii
  • Warszawa, Poland, 02-091
    • Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Pediatrii
• Spain
  • Barcelona, Spain, 08009
    • Fundacion Hospital de Nens
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra
  • Madrid, Spain, 28040
    • Hospital Clinico de San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario de la Paz ,Pediatric Deparment
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz Servicio de Farmacia. Planta baja Edificio Norte
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario de Santiago
  • Barcelona
    • Espluges De Llobregat, Barcelona, Spain, 08950
      • Hospital Universitario Sant Joan de Deu
• Taiwan
  • Hsinchu City, Taiwan, 30071
    • Hsinchu MacKay Memorial Hospital
  • Hualien, Taiwan, 970
    • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Tainan City, Taiwan, 710
    • Chi Mei Medical Center
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
  • Bangkok, Thailand, 10400
    • QueenSirikit National Institute of Child Health {QSNICH}
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital,Faculty of Medicine, Chiang Mai University
  • Chiangrai, Thailand, 57000
    • Chiangrai Prachanukroh Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
  • Phitsanulok, Thailand, 65000
    • Naresuan University Hospital ,Faculty of Medicine, Naresuan University
  • khon Kaen, Thailand, 40002
    • Faculty of Medicine, Khon Kaen University
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University
    • Bangkoknoi, Bangkok, Thailand, 10700
      • The Pharmacy Unit Ground Floor, OPD Building Faculty of Madicine,
    • Patumwan, Bangkok, Thailand, 10330
      • Chula Clinical Research Center, Faculty of Medicine
• United Kingdom
  • Liverpool, United Kingdom, L 12 2AP
    • Alder Hey Children's NHS Foundation Trust Institute in the Park
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust St Mary's Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital Westminster
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust NIHR Clinical Research Facility ,Mailpoint 218,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female ≥ 1 month and ≤ 36 months of age
2. Weight ≥ 3.5 kg
3. Clinical diagnosis of LRTI
4. A positive RSV diagnostic test
5. Hospitalised because of RSV LRTI
6. 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
7. Expected to remain in hospital for a minimum of 3 days
8. 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:

1. Premature (gestational age less than 37 weeks) AND <1 year of post-natal age
2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.
3. Any clinically significant ECG abnormalities.
4. Known to be immunocompromised.
5. High risk of having developing asthma.
6. Suspected of having a clinically significant bacterial infection.
7. History of renal failure.
8. Clinical evidence of hepatic decompensation
9. History of epilepsy or seizures, including febrile seizures
10. Allergy to test medication or constituents
11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous [IV] immunoglobulin) within 3 months before the Screening Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RV521; sisunatovir is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. The RV521 dry powder blend will be supplied in capsules containing 10, 20, or 50 mg RV521. The Investigational Medicinal Product (IMP) will be dispersed in a defined volume of suspending diluent prior to oral administration on a mg/kg basis. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual. The proposed dosing regimen for Part A is a single open label dose of RV521. Part B and C is RV521 or placebo administered BID, 12 hours apart, for a period of 5 consecutive days with a total of 10 doses. However, this is subject to the recommendation of the DSMC.	Drug: RV521; RV521 is an RSV F protein inhibitor administered orally; Other Names: sisunatovir
Placebo Comparator: Placebo; The placebo capsules administered in Part B and C will contain mannitol and microcrystalline cellulose (vehicle). The placebo dry powder will be dispersed in suspending diluent and given orally BID. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.	Drug: Placebo; vehicle administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing incidence of AEs, TEAEs, SAEs, and withdrawals due to TEAEs.	Summary tables of AEs will be based on TEAEs, defined as events starting, or worsening, after the first dose of IMP.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing changes in physical examinations.	Results at each visit will be summarised using the statistics: n (number of observations), mean, SD, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing systolic BP (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing diastolic BP (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing body temperature (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing respiration rate (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing heart rate (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing pulse oximetry (vital sign parameters) and changes from baseline	Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Number of participants with changes in haematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline in Part A and Part B.	Results at each visit will be summarised using the statistics n, mean, standard deviation, median, minimum and maximum. Also, change from baseline will also be summarised by post baseline visits.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Number of participants with changes in ECG measurements from baseline in Part A and Part B	Parameters collected will be: Ventricular Heart Rate (bpm); PR Interval (msec); QRS Interval (msec); QT Interval (msec); QTcB Interval (msec) Results at each visit will be summarised using the statistics: n (number of observations), mean, SD, median, minimum and maximum.	48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Part C: Evaluate the effect of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to show time to resolution of symptoms.	Overall time to resolution of RSV-related signs and symptoms will be calculated from the time of randomization to the time that they are no longer present (absent or severity =0), and will be summarized and analysed as Time to Improvement.	up to 48 hours post dose 10
Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to change of symptoms.	Time to change in symptoms will be calculated for RSV-related signs and symptoms that are classified as moderate or severe during the course of the study and will be defined as the time from randomization until no longer present (absent or severity=0) or mild (scores ≤ 5).	up to 48 hours post dose 10
Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess change in severity of symptoms	Change in severity of symptoms by RV521, compared to placebo, will be measured by a composite score over time.	up to 48 hours post dose 10
Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess use of supplemental oxygen.	Duration and maximum level of O2 provided will be assessed.	up to 48 hours post dose 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing time to maximum plasma concentration (tmax).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing maximum observed plasma concentration (Cmax).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing area under the plasma concentration time curve from time zero to 12 hours (AUC0-12).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the PK of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing the area under the plasma concentration time curve from time zero to last measurable plasma concentration (AUC0 t).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing terminal half-life (t1/2).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing area under the plasma concentration time curve from time zero to infinity (AUC0-∞).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing predicted plasma clearance.	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing apparent volume of distribution of the drug after extravascular administration (V/F).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing trough concentration at the end of first dosing interval (C12) (data permitting).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 1 (Part A)
To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing accumulation ratio, percent fluctuation.	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 10
To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing the area under the plasma concentration time curve from time zero to the end of last dosing interval (AUC0-tau).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 10
To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing average plasma concentration over dosing interval (Cave).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 10
To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing minimum observed plasma concentration (Cmin).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 10
To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing plasma trough concentration (Ctrough).	Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight.	48 hours post dose 10
Part B: To evaluate the antiviral effects of RV521 in infants hospitalised with RSV LRTI by RSV viral load measured in nasopharyngeal swabs by RT qPCR.	Pharmacodynamics analysis will include listing of results of viral load with summary statistics by dose level and time point.	up to 48 hours post dose 10
Part B: To evaluate the antiviral effects of RV521 in infants hospitalised with RSV LRTI by RSV viral load measured in nasopharyngeal swabs by CBIA.	Pharmacodynamics analysis will include listing of results of viral load with summary statistics by dose level and time point.	up to 48 hours post dose 10
Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to resolution of symptoms.	Overall Time to Resolution of RSV-related signs and symptoms will be calculated from the time of randomization to the time that they are no longer present (absent or severity =0), and will be summarized and analysed as for Time to Improvement.	48 hours post dose 10
Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to improvement evaluated by change in severity of symptoms.	Time to improvement will be calculated for RSV-related signs and symptoms that are classified as moderate or severe during the course of the study and will be defined as the time from randomization until no longer present (absent or severity=0) or mild (scores ≤ 5).	48 hours post dose 10
Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess change in severity of symptoms.	Change in severity of symptoms by RV521, compared to placebo, will be measured by a composite score over time.	48 hours post dose 10

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Children; Pediatrics; Cough; Wheezing; LRTI; Rhinitis; RV521; sisunatovir
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: REVC003; C5241003 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No