Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079320
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2023-10-06
Brief Title:
A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus RSV Infection
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL PHASE 23 ADAPTIVE MULTI-CENTER RANDOMIZED DOUBLE-BLIND STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ORAL SISUNATOVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued due to business reasons There were no safety concerns in the decision to stop study and no changes to sponsors assessment of the risk-benefit profile for participants who received sisunatovir in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the safety and effects of sisunatovir Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus RSV RSV is a virus that causes lung infections with cold-like symptoms but it can cause severe illness in some people Sisunatovir is studied in adults
who are not admitted to the hospital and
who have high chances of having a severe illness from RSV infection
This study is seeking participants who
Are confirmed to have RSV
Have symptoms of a lung infection
Are 18 years of age or older
Have one or more of the following which increases the chances of RSV illness
A long-term lung disease
heart failure
a condition that weakens the immune system
Are 65 years of age or older and do not have any of the conditions above
Half of the participants in this study will receive sisunatovir The other half will receive a placebo for 5 days Placebo looks same like the study medicine but does not have any medication Both sisunatovir and placebo will be taken by mouth The study will compare the experiences of people receiving sisunatovir to those of the people who do not This will help decide if sisunatovir is safe and effective
Participants will attend about 8-10 study visits over 5 weeks During this time they will have
visits at the study clinic
blood work
swabs of the nose
questionnaires
a follow-up phone call
who are not admitted to the hospital and
who have high chances of having a severe illness from RSV infection
This study is seeking participants who
Are confirmed to have RSV
Have symptoms of a lung infection
Are 18 years of age or older
Have one or more of the following which increases the chances of RSV illness
A long-term lung disease
heart failure
a condition that weakens the immune system
Are 65 years of age or older and do not have any of the conditions above
Half of the participants in this study will receive sisunatovir The other half will receive a placebo for 5 days Placebo looks same like the study medicine but does not have any medication Both sisunatovir and placebo will be taken by mouth The study will compare the experiences of people receiving sisunatovir to those of the people who do not This will help decide if sisunatovir is safe and effective
Participants will attend about 8-10 study visits over 5 weeks During this time they will have
visits at the study clinic
blood work
swabs of the nose
questionnaires
a follow-up phone call
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505922-32-01 | REGISTRY | CTIS EU | None |