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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04225897




Registration number
NCT04225897
Ethics application status
Date submitted
11/12/2019
Date registered
13/01/2020
Date last updated
23/10/2024

Titles & IDs
Public title
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
Scientific title
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)
Secondary ID [1] 0 0
C5241003
Secondary ID [2] 0 0
REVC003
Universal Trial Number (UTN)
Trial acronym
REVIRAL 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV) 0 0
Lower Resp Tract Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RV521
Treatment: Drugs - Placebo

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.

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.


Treatment: Drugs: RV521
RV521 is an RSV F protein inhibitor administered orally

Treatment: Drugs: Placebo
vehicle administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
Timepoint [1] 0 0
From start of IMP on Day 1 up to Day 7
Primary outcome [2] 0 0
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
Timepoint [2] 0 0
From start of IMP on Day 1 up to Day 12
Primary outcome [3] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
Timepoint [3] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [4] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose
Timepoint [4] 0 0
Anytime between 18 to 24 hours post-dose on Day 1
Primary outcome [5] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose
Timepoint [5] 0 0
At 48 hours post-dose on Day 1
Primary outcome [6] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
Timepoint [6] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [7] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10
Timepoint [7] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Primary outcome [8] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline
Timepoint [8] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [9] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
Timepoint [9] 0 0
Anytime between 4 to 5 hours post-dose on Day 1
Primary outcome [10] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose
Timepoint [10] 0 0
At 12 hours post-dose on Day 1
Primary outcome [11] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose
Timepoint [11] 0 0
Anytime between 18 to 24 hours post-dose on Day 1
Primary outcome [12] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose
Timepoint [12] 0 0
48 hours post-dose on Day 1
Primary outcome [13] 0 0
Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline
Timepoint [13] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [14] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
Timepoint [14] 0 0
Anytime between 4 to 5 hours post-dose 1 (Day 1)
Primary outcome [15] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2
Timepoint [15] 0 0
Pre-dose 2 (Day 1)
Primary outcome [16] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3
Timepoint [16] 0 0
Pre-dose 3 (Day 2)
Primary outcome [17] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4
Timepoint [17] 0 0
Pre-dose 4 (Day 2)
Primary outcome [18] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5
Timepoint [18] 0 0
Pre-dose 5 (Day 3)
Primary outcome [19] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6
Timepoint [19] 0 0
Pre-dose 6 (Day 3)
Primary outcome [20] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
Timepoint [20] 0 0
Anytime between 4 to 5 hours post-dose 6 (Day 3)
Primary outcome [21] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7
Timepoint [21] 0 0
Pre-dose 7 (Day 4)
Primary outcome [22] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8
Timepoint [22] 0 0
Pre-dose 8 (Day 4)
Primary outcome [23] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9
Timepoint [23] 0 0
Pre-dose 9 (Day 5)
Primary outcome [24] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10
Timepoint [24] 0 0
Pre-dose 10 (Day 5)
Primary outcome [25] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
Timepoint [25] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Primary outcome [26] 0 0
Part A: Number of Participants With Abnormal Hematology Results at Baseline
Timepoint [26] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [27] 0 0
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose
Timepoint [27] 0 0
At 48 hours post-dose on Day 1
Primary outcome [28] 0 0
Part B: Number of Participants With Abnormal Hematology Results at Baseline
Timepoint [28] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [29] 0 0
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10
Timepoint [29] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Primary outcome [30] 0 0
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
Timepoint [30] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [31] 0 0
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose
Timepoint [31] 0 0
At 48 hours post-dose on Day 1
Primary outcome [32] 0 0
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
Timepoint [32] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [33] 0 0
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10
Timepoint [33] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Primary outcome [34] 0 0
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline
Timepoint [34] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [35] 0 0
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose
Timepoint [35] 0 0
At 48 hours post-dose on Day 1
Primary outcome [36] 0 0
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline
Timepoint [36] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [37] 0 0
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10
Timepoint [37] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Primary outcome [38] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
Timepoint [38] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [39] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
Timepoint [39] 0 0
Anytime between 4 to 5 hours post-dose on Day 1
Primary outcome [40] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose
Timepoint [40] 0 0
Anytime between 18 to 24 hours post-dose on Day 1
Primary outcome [41] 0 0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose
Timepoint [41] 0 0
48 hours post-dose on Day 1
Primary outcome [42] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
Timepoint [42] 0 0
Baseline (pre-dose on Day 1)
Primary outcome [43] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
Timepoint [43] 0 0
Anytime between 4 to 5 hours post-dose 1 on Day 1
Primary outcome [44] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3
Timepoint [44] 0 0
Pre-dose 3 (Day 2)
Primary outcome [45] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5
Timepoint [45] 0 0
Pre-dose 5 (Day 3)
Primary outcome [46] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
Timepoint [46] 0 0
Anytime between 4 to 5 hours post-dose 6 (Day 3)
Primary outcome [47] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8
Timepoint [47] 0 0
Pre-dose 8 (Day 4)
Primary outcome [48] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10
Timepoint [48] 0 0
Pre-dose 10 (Day 5)
Primary outcome [49] 0 0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
Timepoint [49] 0 0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Secondary outcome [1] 0 0
Part A: Time to Maximum Plasma Concentration (Tmax)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Part B: Time to Maximum Plasma Concentration (Tmax)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Part A: Maximum Observed Plasma Concentration (Cmax)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Part B: Maximum Observed Plasma Concentration (Cmax)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
Timepoint [5] 0 0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1
Secondary outcome [6] 0 0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Part A: Terminal Half-life (t1/2)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Part B: Terminal Half-life (t1/2)
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Part A: Trough Concentration at the End of First Dosing Interval (C12)
Timepoint [13] 0 0
At 12 hours post-dose on Day 1
Secondary outcome [14] 0 0
Part B: Trough Concentration at the End of Dose 6 (C12)
Timepoint [14] 0 0
At 12 hours post-dose 6
Secondary outcome [15] 0 0
Part A: Predicted Plasma Clearance
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Part B: Predicted Plasma Clearance
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration
Timepoint [18] 0 0
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)
Secondary outcome [19] 0 0
Part B: Accumulation Ratio
Timepoint [19] 0 0
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)
Secondary outcome [20] 0 0
Part B: Percentage Fluctuation
Timepoint [20] 0 0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Secondary outcome [21] 0 0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)
Timepoint [21] 0 0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Secondary outcome [22] 0 0
Part B: Average Plasma Concentration Over Dosing Interval (Cavg)
Timepoint [22] 0 0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Secondary outcome [23] 0 0
Part B: Minimum Observed Plasma Concentration
Timepoint [23] 0 0
Day 3 Dose 6 (pre-dose)
Secondary outcome [24] 0 0
Part B: Plasma Trough Concentration
Timepoint [24] 0 0
Day 3 Dose 6 (pre-dose)
Secondary outcome [25] 0 0
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Timepoint [25] 0 0
Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Secondary outcome [26] 0 0
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)
Timepoint [26] 0 0
Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Secondary outcome [27] 0 0
Part B: Time to Resolution of RSV-Related Signs and Symptoms
Timepoint [27] 0 0
Up to Day 12
Secondary outcome [28] 0 0
Part B: Time to Improvement in RSV-Related Signs and Symptoms
Timepoint [28] 0 0
Up to Day 12
Secondary outcome [29] 0 0
Part B: RSV Clinical Scoring System Scores
Timepoint [29] 0 0
Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5

Eligibility
Key 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
Minimum age
1 Month
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Chile
State/province [4] 0 0
Metropolitana
Country [5] 0 0
Chile
State/province [5] 0 0
Region DE LOS Lagos
Country [6] 0 0
Costa Rica
State/province [6] 0 0
San Jose
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Hungary
State/province [8] 0 0
Kaposvar
Country [9] 0 0
Israel
State/province [9] 0 0
Beer-Sheva
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Petach Tikava
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kelantan
Country [14] 0 0
Malaysia
State/province [14] 0 0
Perak
Country [15] 0 0
Malaysia
State/province [15] 0 0
Pulau Pinang
Country [16] 0 0
Malaysia
State/province [16] 0 0
Sarawak
Country [17] 0 0
Malaysia
State/province [17] 0 0
Terengganu
Country [18] 0 0
Malaysia
State/province [18] 0 0
Parek
Country [19] 0 0
New Zealand
State/province [19] 0 0
Wellington
Country [20] 0 0
Panama
State/province [20] 0 0
Panama
Country [21] 0 0
Poland
State/province [21] 0 0
Krakow
Country [22] 0 0
Poland
State/province [22] 0 0
Lodz
Country [23] 0 0
Poland
State/province [23] 0 0
Warszawa
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Pamplona
Country [27] 0 0
Spain
State/province [27] 0 0
Santiago de Compostela
Country [28] 0 0
Taiwan
State/province [28] 0 0
Hsinchu City
Country [29] 0 0
Taiwan
State/province [29] 0 0
Hualien
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung City
Country [31] 0 0
Taiwan
State/province [31] 0 0
Tainan City
Country [32] 0 0
Thailand
State/province [32] 0 0
Bangkok
Country [33] 0 0
Thailand
State/province [33] 0 0
Chiang Mai
Country [34] 0 0
Thailand
State/province [34] 0 0
Chiangrai
Country [35] 0 0
Thailand
State/province [35] 0 0
khon Kaen
Country [36] 0 0
Thailand
State/province [36] 0 0
Khon Kaen
Country [37] 0 0
Thailand
State/province [37] 0 0
Phitsanulok
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Liverpool
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT04225897
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04225897