Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05148780 | A Study of Acute Respiratory Infections in Global Outpatient Setting | EARLY_PHASE1 | COMPLETED | 245 | — | — | Dec 20, 2021 | Feb 22, 2023 | Feb 3, 2025 | 72 | United States, Canada +8 |
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Number of participants with relative risk of ARI-related hospitalization in participants positive for RSV with LRTD or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the Respiratory Infection Intensity and Impact Questionnaire (RiiQTM) V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
| Arm | Type | Description |
|---|---|---|
| Participants with Acute Respiratory Infections (ARI) in Outpatient Setting | OTHER | Participants presenting with ARIs in an outpatient setting who are at high risk of progressing to severe disease will be screened for viral respiratory pathogens (respiratory syncytial virus \[RSV\], Influenza, severe acute respiratory syndrome coronavirus 2 \[SARS-COV-2\]) by collecting a nasal swab. If a participant is positive for RSV and/or influenza virus and/or SARS-CoV-2 based on a study test or standard-of-care (SOC) polymerase chain reaction (PCR)-based test, the participant will be eligible for enrollment in the study in the home-based short-term and long-term follow-up phases. |
| Name | Type | Description |
|---|---|---|
| Nasal Swab Sample | DIAGNOSTIC_TEST | Nasal swab sample will be used to screen participants for detection of viral pathogens. No intervention or study drug will be administered as part of this study. |
Inclusion Criteria: * Present to the general physician (GP)/specialist outpatient settings/respiratory clinics or in Emergency department (ED) settings with symptoms suggestive of a diagnosis of Acute Respiratory Infections (ARI) * For inclusion in the home-based follow-up phases, must test positiv...