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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

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]

C5241003

Secondary ID [2]

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)

Lower Resp Tract Infection

Condition category

Condition code

Infection

Studies of infection and infectious agents

Infection

Other infectious diseases

Infection

Sexually transmitted infections

Respiratory

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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]

From start of IMP on Day 1 up to Day 7

Primary outcome [2]

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]

From start of IMP on Day 1 up to Day 12

Primary outcome [3]

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

Timepoint [3]

Baseline (pre-dose on Day 1)

Primary outcome [4]

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

Timepoint [4]

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

Primary outcome [5]

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

Timepoint [5]

At 48 hours post-dose on Day 1

Primary outcome [6]

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

Timepoint [6]

Baseline (pre-dose on Day 1)

Primary outcome [7]

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

Timepoint [7]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Primary outcome [8]

Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline

Timepoint [8]

Baseline (pre-dose on Day 1)

Primary outcome [9]

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]

Anytime between 4 to 5 hours post-dose on Day 1

Primary outcome [10]

Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose

Timepoint [10]

At 12 hours post-dose on Day 1

Primary outcome [11]

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]

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

Primary outcome [12]

Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose

Timepoint [12]

48 hours post-dose on Day 1

Primary outcome [13]

Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline

Timepoint [13]

Baseline (pre-dose on Day 1)

Primary outcome [14]

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]

Anytime between 4 to 5 hours post-dose 1 (Day 1)

Primary outcome [15]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2

Timepoint [15]

Pre-dose 2 (Day 1)

Primary outcome [16]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3

Timepoint [16]

Pre-dose 3 (Day 2)

Primary outcome [17]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4

Timepoint [17]

Pre-dose 4 (Day 2)

Primary outcome [18]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5

Timepoint [18]

Pre-dose 5 (Day 3)

Primary outcome [19]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6

Timepoint [19]

Pre-dose 6 (Day 3)

Primary outcome [20]

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]

Anytime between 4 to 5 hours post-dose 6 (Day 3)

Primary outcome [21]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7

Timepoint [21]

Pre-dose 7 (Day 4)

Primary outcome [22]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8

Timepoint [22]

Pre-dose 8 (Day 4)

Primary outcome [23]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9

Timepoint [23]

Pre-dose 9 (Day 5)

Primary outcome [24]

Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10

Timepoint [24]

Pre-dose 10 (Day 5)

Primary outcome [25]

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]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Primary outcome [26]

Part A: Number of Participants With Abnormal Hematology Results at Baseline

Timepoint [26]

Baseline (pre-dose on Day 1)

Primary outcome [27]

Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose

Timepoint [27]

At 48 hours post-dose on Day 1

Primary outcome [28]

Part B: Number of Participants With Abnormal Hematology Results at Baseline

Timepoint [28]

Baseline (pre-dose on Day 1)

Primary outcome [29]

Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10

Timepoint [29]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Primary outcome [30]

Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline

Timepoint [30]

Baseline (pre-dose on Day 1)

Primary outcome [31]

Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose

Timepoint [31]

At 48 hours post-dose on Day 1

Primary outcome [32]

Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline

Timepoint [32]

Baseline (pre-dose on Day 1)

Primary outcome [33]

Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10

Timepoint [33]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Primary outcome [34]

Part A: Number of Participants With Abnormal Urinalysis Results at Baseline

Timepoint [34]

Baseline (pre-dose on Day 1)

Primary outcome [35]

Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose

Timepoint [35]

At 48 hours post-dose on Day 1

Primary outcome [36]

Part B: Number of Participants With Abnormal Urinalysis Results at Baseline

Timepoint [36]

Baseline (pre-dose on Day 1)

Primary outcome [37]

Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10

Timepoint [37]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Primary outcome [38]

Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline

Timepoint [38]

Baseline (pre-dose on Day 1)

Primary outcome [39]

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]

Anytime between 4 to 5 hours post-dose on Day 1

Primary outcome [40]

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]

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

Primary outcome [41]

Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose

Timepoint [41]

48 hours post-dose on Day 1

Primary outcome [42]

Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline

Timepoint [42]

Baseline (pre-dose on Day 1)

Primary outcome [43]

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]

Anytime between 4 to 5 hours post-dose 1 on Day 1

Primary outcome [44]

Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3

Timepoint [44]

Pre-dose 3 (Day 2)

Primary outcome [45]

Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5

Timepoint [45]

Pre-dose 5 (Day 3)

Primary outcome [46]

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]

Anytime between 4 to 5 hours post-dose 6 (Day 3)

Primary outcome [47]

Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8

Timepoint [47]

Pre-dose 8 (Day 4)

Primary outcome [48]

Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10

Timepoint [48]

Pre-dose 10 (Day 5)

Primary outcome [49]

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]

Anytime between 40 to 48 hours post-dose 10 on Day 5

Secondary outcome [1]

Part A: Time to Maximum Plasma Concentration (Tmax)

Timepoint [1]

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]

Part B: Time to Maximum Plasma Concentration (Tmax)

Timepoint [2]

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]

Part A: Maximum Observed Plasma Concentration (Cmax)

Timepoint [3]

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]

Part B: Maximum Observed Plasma Concentration (Cmax)

Timepoint [4]

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]

Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

Timepoint [5]

Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1

Secondary outcome [6]

Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

Timepoint [6]

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]

Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

Timepoint [7]

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]

Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

Timepoint [8]

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]

Part A: Terminal Half-life (t1/2)

Timepoint [9]

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]

Part B: Terminal Half-life (t1/2)

Timepoint [10]

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]

Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)

Timepoint [11]

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]

Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)

Timepoint [12]

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]

Part A: Trough Concentration at the End of First Dosing Interval (C12)

Timepoint [13]

At 12 hours post-dose on Day 1

Secondary outcome [14]

Part B: Trough Concentration at the End of Dose 6 (C12)

Timepoint [14]

At 12 hours post-dose 6

Secondary outcome [15]

Part A: Predicted Plasma Clearance

Timepoint [15]

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]

Part B: Predicted Plasma Clearance

Timepoint [16]

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]

Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration

Timepoint [17]

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]

Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration

Timepoint [18]

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]

Part B: Accumulation Ratio

Timepoint [19]

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]

Part B: Percentage Fluctuation

Timepoint [20]

Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Secondary outcome [21]

Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)

Timepoint [21]

Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Secondary outcome [22]

Part B: Average Plasma Concentration Over Dosing Interval (Cavg)

Timepoint [22]

Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

Secondary outcome [23]

Part B: Minimum Observed Plasma Concentration

Timepoint [23]

Day 3 Dose 6 (pre-dose)

Secondary outcome [24]

Part B: Plasma Trough Concentration

Timepoint [24]

Day 3 Dose 6 (pre-dose)

Secondary outcome [25]

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]

Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

Secondary outcome [26]

Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)

Timepoint [26]

Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

Secondary outcome [27]

Part B: Time to Resolution of RSV-Related Signs and Symptoms

Timepoint [27]

Up to Day 12

Secondary outcome [28]

Part B: Time to Improvement in RSV-Related Signs and Symptoms

Timepoint [28]

Up to Day 12

Secondary outcome [29]

Part B: RSV Clinical Scoring System Scores

Timepoint [29]

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?

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

13/11/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

5/12/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

Argentina

State/province [1]

Buenos Aires

Country [2]

Argentina

State/province [2]

Caba

Country [3]

Canada

State/province [3]

Alberta

Country [4]

Chile

State/province [4]

Metropolitana

Country [5]

Chile

State/province [5]

Region DE LOS Lagos

Country [6]

Costa Rica

State/province [6]

San Jose

Country [7]

Hungary

State/province [7]

Budapest

Country [8]

Hungary

State/province [8]

Kaposvar

Country [9]

Israel

State/province [9]

Beer-Sheva

Country [10]

Israel

State/province [10]

Haifa

Country [11]

Israel

State/province [11]

Petach Tikava

Country [12]

Korea, Republic of

State/province [12]

Seoul

Country [13]

Malaysia

State/province [13]

Kelantan

Country [14]

Malaysia

State/province [14]

Perak

Country [15]

Malaysia

State/province [15]

Pulau Pinang

Country [16]

Malaysia

State/province [16]

Sarawak

Country [17]

Malaysia

State/province [17]

Terengganu

Country [18]

Malaysia

State/province [18]

Parek

Country [19]

New Zealand

State/province [19]

Wellington

Country [20]

Panama

State/province [20]

Panama

Country [21]

Poland

State/province [21]

Krakow

Country [22]

Poland

State/province [22]

Lodz

Country [23]

Poland

State/province [23]

Warszawa

Country [24]

Spain

State/province [24]

Barcelona

Country [25]

Spain

State/province [25]

Madrid

Country [26]

Spain

State/province [26]

Pamplona

Country [27]

Spain

State/province [27]

Santiago de Compostela

Country [28]

Taiwan

State/province [28]

Hsinchu City

Country [29]

Taiwan

State/province [29]

Hualien

Country [30]

Taiwan

State/province [30]

Kaohsiung City

Country [31]

Taiwan

State/province [31]

Tainan City

Country [32]

Thailand

State/province [32]

Bangkok

Country [33]

Thailand

State/province [33]

Chiang Mai

Country [34]

Thailand

State/province [34]

Chiangrai

Country [35]

Thailand

State/province [35]

khon Kaen

Country [36]

Thailand

State/province [36]

Khon Kaen

Country [37]

Thailand

State/province [37]

Phitsanulok

Country [38]

United Kingdom

State/province [38]

Liverpool

Country [39]

United Kingdom

State/province [39]

London

Country [40]

United Kingdom

State/province [40]

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

Pfizer CT.gov Call Center

Address

Pfizer

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

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.

When will data be available (start and end dates)?

Available to whom?

Available for what types of analyses?

How or where can data be obtained?

IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/97/NCT04225897/Prot_000.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/97/NCT04225897/SAP_001.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04225897

Register a trial

Registering a new trial?

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